PriceTracker GLP-1

What FDA’s records state

FDA listing summary for Eli Lilly and Company
FieldWhat FDA’s record statesSource
Firm, as FDA lists itEli Lilly and CompanyopenFDA NDC
Also listed asNo other spellingopenFDA NDC
FDA labeler code0002openFDA NDC
MoleculesTirzepatide, Dulaglutide, OrforglipronopenFDA NDC
Kinds of listingApproved product: 58 · Unfinished, for further processing: 2 · Bulk ingredient: 1openFDA NDC
Products and packages61 products, 72 package NDCsopenFDA NDC
Earliest listing dateSep 18, 2014openFDA NDC
Latest listing dateApr 1, 2026openFDA NDC
Approved applications citedBLA125469 (TRULICITY), held by ELI LILLY AND CO, first approved Sep 18, 2014NDA215866 (MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN), held by ELI LILLY AND CO, first approved May 13, 2022NDA217806 (ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN), held by ELI LILLY AND CO, first approved Nov 8, 2023NDA220934 (FOUNDAYO), held by ELI LILLY AND CO, first approved Apr 1, 2026Drugs@FDA

Every GLP-1 product Eli Lilly and Company lists

One row per product NDC, in FDA’s words. Strength is printed as FDA lists it, spacing tidied.

GLP-1 products listed with FDA by Eli Lilly and Company
ProductProduct NDCForm and strengthFDA categoryListedPackages
MounjaroTirzepatide0002-1152Injection, Solution · Subcutaneous2.5 mg/0.5 mLApproved productNDA · NDA215866Since Jul 28, 2023Certified through Dec 31, 2027
1 package
  • 0002-1152-01 1 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE, since Jul 28, 2023
MounjaroTirzepatide0002-1243Injection, Solution · Subcutaneous5 mg/0.5 mLApproved productNDA · NDA215866Since Jul 28, 2023Certified through Dec 31, 2027
1 package
  • 0002-1243-01 1 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE, since Jul 28, 2023
MounjaroTirzepatide0002-1457Injection, Solution · Subcutaneous15 mg/0.5 mLApproved productNDA · NDA215866Since May 13, 2022Certified through Dec 31, 2027
1 package
  • 0002-1457-80 4 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE, since May 13, 2022
MounjaroTirzepatide0002-1460Injection, Solution · Subcutaneous12.5 mg/0.5 mLApproved productNDA · NDA215866Since May 13, 2022Certified through Dec 31, 2027
1 package
  • 0002-1460-80 4 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE, since May 13, 2022
MounjaroTirzepatide0002-1471Injection, Solution · Subcutaneous10 mg/0.5 mLApproved productNDA · NDA215866Since May 13, 2022Certified through Dec 31, 2027
1 package
  • 0002-1471-80 4 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE, since May 13, 2022
MounjaroTirzepatide0002-1484Injection, Solution · Subcutaneous7.5 mg/0.5 mLApproved productNDA · NDA215866Since May 13, 2022Certified through Dec 31, 2027
1 package
  • 0002-1484-80 4 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE, since May 13, 2022
MounjaroTirzepatide0002-1495Injection, Solution · Subcutaneous5 mg/0.5 mLApproved productNDA · NDA215866Since May 13, 2022Certified through Dec 31, 2027
1 package
  • 0002-1495-80 4 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE, since May 13, 2022
MounjaroTirzepatide0002-1506Injection, Solution · Subcutaneous2.5 mg/0.5 mLApproved productNDA · NDA215866Since May 13, 2022Certified through Dec 31, 2027
2 packages
  • 0002-1506-61 4 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE, since Jun 8, 2022
  • 0002-1506-80 4 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE, since May 13, 2022
MounjaroTirzepatide0002-2214Injection, Solution · Subcutaneous7.5 mg/0.5 mLApproved productNDA · NDA215866Since Jul 28, 2023Certified through Dec 31, 2027
1 package
  • 0002-2214-01 1 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE, since Jul 28, 2023
MounjaroTirzepatide0002-2340Injection, Solution · Subcutaneous10 mg/0.5 mLApproved productNDA · NDA215866Since Jul 28, 2023Certified through Dec 31, 2027
1 package
  • 0002-2340-01 1 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE, since Jul 28, 2023
MounjaroTirzepatide0002-2423Injection, Solution · Subcutaneous12.5 mg/0.5 mLApproved productNDA · NDA215866Since Jul 28, 2023Certified through Dec 31, 2027
1 package
  • 0002-2423-01 1 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE, since Jul 28, 2023
MounjaroTirzepatide0002-3002Injection, Solution · Subcutaneous15 mg/0.5 mLApproved productNDA · NDA215866Since Jul 28, 2023Certified through Dec 31, 2027
1 package
  • 0002-3002-01 1 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE, since Jul 28, 2023
MounjaroTirzepatide0002-4052Injection, Solution · Subcutaneous4.17 mg/mLApproved productNDA · NDA215866Since Jan 7, 2026Certified through Dec 31, 2027
1 package
  • 0002-4052-11 1 VIAL, MULTI-DOSE in 1 CARTON / 2.4 mL in 1 VIAL, MULTI-DOSE, since Jan 7, 2026
MounjaroTirzepatide0002-4103Injection, Solution · Subcutaneous8.33 mg/mLApproved productNDA · NDA215866Since Jan 7, 2026Certified through Dec 31, 2027
1 package
  • 0002-4103-11 1 VIAL, MULTI-DOSE in 1 CARTON / 2.4 mL in 1 VIAL, MULTI-DOSE, since Jan 7, 2026
MounjaroTirzepatide0002-4210Injection, Solution · Subcutaneous12.5 mg/mLApproved productNDA · NDA215866Since Jan 7, 2026Certified through Dec 31, 2027
1 package
  • 0002-4210-11 1 VIAL, MULTI-DOSE in 1 CARTON / 2.4 mL in 1 VIAL, MULTI-DOSE, since Jan 7, 2026
MounjaroTirzepatide0002-4304Injection, Solution · Subcutaneous16.7 mg/mLApproved productNDA · NDA215866Since Jan 7, 2026Certified through Dec 31, 2027
1 package
  • 0002-4304-11 1 VIAL, MULTI-DOSE in 1 CARTON / 2.4 mL in 1 VIAL, MULTI-DOSE, since Jan 7, 2026
MounjaroTirzepatide0002-4523Injection, Solution · Subcutaneous20.8 mg/mLApproved productNDA · NDA215866Since Jan 7, 2026Certified through Dec 31, 2027
1 package
  • 0002-4523-11 1 VIAL, MULTI-DOSE in 1 CARTON / 2.4 mL in 1 VIAL, MULTI-DOSE, since Jan 7, 2026
MounjaroTirzepatide0002-4612Injection, Solution · Subcutaneous25 mg/mLApproved productNDA · NDA215866Since Jan 7, 2026Certified through Dec 31, 2027
1 package
  • 0002-4612-11 1 VIAL, MULTI-DOSE in 1 CARTON / 2.4 mL in 1 VIAL, MULTI-DOSE, since Jan 7, 2026
Mounjaro KwikPen KwikPenTirzepatide0002-3411Injection, Solution · Subcutaneous25 mg/mLApproved productNDA · NDA215866Since Jan 20, 2026Certified through Dec 31, 2027
1 package
  • 0002-3411-11 1 SYRINGE in 1 CARTON / 2.4 mL in 1 SYRINGE, since Jan 20, 2026
Mounjaro KwikPen KwikPenTirzepatide0002-3422Injection, Solution · Subcutaneous20.8 mg/mLApproved productNDA · NDA215866Since Jan 20, 2026Certified through Dec 31, 2027
1 package
  • 0002-3422-11 1 SYRINGE in 1 CARTON / 2.4 mL in 1 SYRINGE, since Jan 20, 2026
Mounjaro KwikPen KwikPenTirzepatide0002-3433Injection, Solution · Subcutaneous16.7 mg/mLApproved productNDA · NDA215866Since Jan 20, 2026Certified through Dec 31, 2027
1 package
  • 0002-3433-11 1 SYRINGE in 1 CARTON / 2.4 mL in 1 SYRINGE, since Jan 20, 2026
Mounjaro KwikPen KwikPenTirzepatide0002-3444Injection, Solution · Subcutaneous12.5 mg/mLApproved productNDA · NDA215866Since Jan 20, 2026Certified through Dec 31, 2027
1 package
  • 0002-3444-11 1 SYRINGE in 1 CARTON / 2.4 mL in 1 SYRINGE, since Jan 20, 2026
Mounjaro KwikPen KwikPenTirzepatide0002-3455Injection, Solution · Subcutaneous8.33 mg/mLApproved productNDA · NDA215866Since Jan 20, 2026Certified through Dec 31, 2027
1 package
  • 0002-3455-11 1 SYRINGE in 1 CARTON / 2.4 mL in 1 SYRINGE, since Jan 20, 2026
Mounjaro KwikPen KwikPenTirzepatide0002-3466Injection, Solution · Subcutaneous4.17 mg/mLApproved productNDA · NDA215866Since Jan 20, 2026Certified through Dec 31, 2027
1 package
  • 0002-3466-11 1 SYRINGE in 1 CARTON / 2.4 mL in 1 SYRINGE, since Jan 20, 2026
ZepboundTirzepatide0002-0152Injection, Solution · Subcutaneous2.5 mg/0.5 mLApproved productNDA · NDA217806Since Mar 28, 2024Certified through Dec 31, 2027
3 packages
  • 0002-0152-01 1 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE, since Mar 28, 2024
  • 0002-0152-04 4 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE, since Aug 8, 2024
  • 0002-0152-61 4 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE, since May 1, 2025
ZepboundTirzepatide0002-0243Injection, Solution · Subcutaneous5 mg/0.5 mLApproved productNDA · NDA217806Since Mar 28, 2024Certified through Dec 31, 2027
2 packages
  • 0002-0243-01 1 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE, since Mar 28, 2024
  • 0002-0243-04 4 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE, since Aug 8, 2024
ZepboundTirzepatide0002-1214Injection, Solution · Subcutaneous7.5 mg/0.5 mLApproved productNDA · NDA217806Since Mar 28, 2024Certified through Dec 31, 2027
2 packages
  • 0002-1214-01 1 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE, since Mar 28, 2024
  • 0002-1214-04 4 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE, since Feb 18, 2025
ZepboundTirzepatide0002-1340Injection, Solution · Subcutaneous10 mg/0.5 mLApproved productNDA · NDA217806Since Mar 28, 2024Certified through Dec 31, 2027
2 packages
  • 0002-1340-01 1 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE, since Mar 28, 2024
  • 0002-1340-04 4 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE, since Feb 18, 2025
ZepboundTirzepatide0002-1423Injection, Solution · Subcutaneous12.5 mg/0.5 mLApproved productNDA · NDA217806Since Mar 28, 2024Certified through Dec 31, 2027
2 packages
  • 0002-1423-01 1 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE, since Mar 28, 2024
  • 0002-1423-04 4 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE, since Jul 7, 2025
ZepboundTirzepatide0002-2002Injection, Solution · Subcutaneous15 mg/0.5 mLApproved productNDA · NDA217806Since Mar 28, 2024Certified through Dec 31, 2027
2 packages
  • 0002-2002-01 1 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE, since Mar 28, 2024
  • 0002-2002-04 4 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE, since Jul 7, 2025
ZepboundTirzepatide0002-6052Injection, Solution · Subcutaneous4.17 mg/mLApproved productNDA · NDA217806Since Jan 7, 2026Certified through Dec 31, 2027
1 package
  • 0002-6052-11 1 VIAL, MULTI-DOSE in 1 CARTON / 2.4 mL in 1 VIAL, MULTI-DOSE, since Jan 7, 2026
ZepboundTirzepatide0002-6103Injection, Solution · Subcutaneous8.33 mg/mLApproved productNDA · NDA217806Since Jan 7, 2026Certified through Dec 31, 2027
1 package
  • 0002-6103-11 1 VIAL, MULTI-DOSE in 1 CARTON / 2.4 mL in 1 VIAL, MULTI-DOSE, since Jan 7, 2026
ZepboundTirzepatide0002-6210Injection, Solution · Subcutaneous12.5 mg/mLApproved productNDA · NDA217806Since Jan 7, 2026Certified through Dec 31, 2027
1 package
  • 0002-6210-11 1 VIAL, MULTI-DOSE in 1 CARTON / 2.4 mL in 1 VIAL, MULTI-DOSE, since Jan 7, 2026
ZepboundTirzepatide0002-6304Injection, Solution · Subcutaneous16.7 mg/mLApproved productNDA · NDA217806Since Jan 7, 2026Certified through Dec 31, 2027
1 package
  • 0002-6304-11 1 VIAL, MULTI-DOSE in 1 CARTON / 2.4 mL in 1 VIAL, MULTI-DOSE, since Jan 7, 2026
ZepboundTirzepatide0002-6523Injection, Solution · Subcutaneous20.8 mg/mLApproved productNDA · NDA217806Since Jan 7, 2026Certified through Dec 31, 2027
1 package
  • 0002-6523-11 1 VIAL, MULTI-DOSE in 1 CARTON / 2.4 mL in 1 VIAL, MULTI-DOSE, since Jan 7, 2026
ZepboundTirzepatide0002-6612Injection, Solution · Subcutaneous25 mg/mLApproved productNDA · NDA217806Since Jan 7, 2026Certified through Dec 31, 2027
1 package
  • 0002-6612-11 1 VIAL, MULTI-DOSE in 1 CARTON / 2.4 mL in 1 VIAL, MULTI-DOSE, since Jan 7, 2026
ZepboundTirzepatide0002-2457Injection, Solution · Subcutaneous15 mg/0.5 mLApproved productNDA · NDA217806Since Nov 8, 2023Certified through Dec 31, 2027
1 package
  • 0002-2457-80 4 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE, since Nov 8, 2023
ZepboundTirzepatide0002-2460Injection, Solution · Subcutaneous12.5 mg/0.5 mLApproved productNDA · NDA217806Since Nov 8, 2023Certified through Dec 31, 2027
1 package
  • 0002-2460-80 4 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE, since Nov 8, 2023
ZepboundTirzepatide0002-2471Injection, Solution · Subcutaneous10 mg/0.5 mLApproved productNDA · NDA217806Since Nov 8, 2023Certified through Dec 31, 2027
1 package
  • 0002-2471-80 4 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE, since Nov 8, 2023
ZepboundTirzepatide0002-2484Injection, Solution · Subcutaneous7.5 mg/0.5 mLApproved productNDA · NDA217806Since Nov 8, 2023Certified through Dec 31, 2027
1 package
  • 0002-2484-80 4 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE, since Nov 8, 2023
ZepboundTirzepatide0002-2495Injection, Solution · Subcutaneous5 mg/0.5 mLApproved productNDA · NDA217806Since Nov 8, 2023Certified through Dec 31, 2027
1 package
  • 0002-2495-80 4 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE, since Nov 8, 2023
ZepboundTirzepatide0002-2506Injection, Solution · Subcutaneous2.5 mg/0.5 mLApproved productNDA · NDA217806Since Nov 8, 2023Certified through Dec 31, 2027
2 packages
  • 0002-2506-61 4 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE, since Nov 8, 2023
  • 0002-2506-80 4 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE, since Nov 8, 2023
Zepbound KwikPen KwikPenTirzepatide0002-3511Injection, Solution · Subcutaneous25 mg/mLApproved productNDA · NDA217806Since Jan 20, 2026Certified through Dec 31, 2027
1 package
  • 0002-3511-11 1 SYRINGE in 1 CARTON / 2.4 mL in 1 SYRINGE, since Jan 20, 2026
Zepbound KwikPen KwikPenTirzepatide0002-3522Injection, Solution · Subcutaneous20.8 mg/mLApproved productNDA · NDA217806Since Jan 20, 2026Certified through Dec 31, 2027
1 package
  • 0002-3522-11 1 SYRINGE in 1 CARTON / 2.4 mL in 1 SYRINGE, since Jan 20, 2026
Zepbound KwikPen KwikPenTirzepatide0002-3533Injection, Solution · Subcutaneous16.7 mg/mLApproved productNDA · NDA217806Since Jan 20, 2026Certified through Dec 31, 2027
1 package
  • 0002-3533-11 1 SYRINGE in 1 CARTON / 2.4 mL in 1 SYRINGE, since Jan 20, 2026
Zepbound KwikPen KwikPenTirzepatide0002-3544Injection, Solution · Subcutaneous12.5 mg/mLApproved productNDA · NDA217806Since Jan 20, 2026Certified through Dec 31, 2027
1 package
  • 0002-3544-11 1 SYRINGE in 1 CARTON / 2.4 mL in 1 SYRINGE, since Jan 20, 2026
Zepbound KwikPen KwikPenTirzepatide0002-3555Injection, Solution · Subcutaneous8.33 mg/mLApproved productNDA · NDA217806Since Jan 20, 2026Certified through Dec 31, 2027
1 package
  • 0002-3555-11 1 SYRINGE in 1 CARTON / 2.4 mL in 1 SYRINGE, since Jan 20, 2026
Zepbound KwikPen KwikPenTirzepatide0002-3566Injection, Solution · Subcutaneous4.17 mg/mLApproved productNDA · NDA217806Since Jan 20, 2026Certified through Dec 31, 2027
2 packages
  • 0002-3566-11 1 SYRINGE in 1 CARTON / 2.4 mL in 1 SYRINGE, since Jan 20, 2026
  • 0002-3566-99 1 SYRINGE in 1 CARTON / 2.4 mL in 1 SYRINGE, since Mar 1, 2026
TrulicityDulaglutide0002-1433Injection, Solution · Subcutaneous0.75 mg/0.5 mLApproved productBLA · BLA125469Since Sep 18, 2014Certified through Dec 31, 2027
1 package
  • 0002-1433-80 4 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE, since Nov 7, 2014
TrulicityDulaglutide0002-1434Injection, Solution · Subcutaneous1.5 mg/0.5 mLApproved productBLA · BLA125469Since Sep 18, 2014Certified through Dec 31, 2027
1 package
  • 0002-1434-80 4 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE, since Nov 7, 2014
TrulicityDulaglutide0002-2236Injection, Solution · Subcutaneous3 mg/0.5 mLApproved productBLA · BLA125469Since Sep 3, 2020Certified through Dec 31, 2027
1 package
  • 0002-2236-80 4 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE, since Sep 3, 2020
TrulicityDulaglutide0002-3182Injection, Solution · Subcutaneous4.5 mg/0.5 mLApproved productBLA · BLA125469Since Sep 3, 2020Certified through Dec 31, 2027
1 package
  • 0002-3182-80 4 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE, since Sep 3, 2020
FoundayoOrforglipron0002-4178Tablet, Film Coated · Oral0.8 mgApproved productNDA · NDA220934Since Apr 1, 2026Certified through Dec 31, 2027
2 packages
  • 0002-4178-31 1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE, since Apr 1, 2026
  • 0002-4178-62 1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE, since Apr 1, 2026
FoundayoOrforglipron0002-4503Tablet, Film Coated · Oral2.5 mgApproved productNDA · NDA220934Since Apr 1, 2026Certified through Dec 31, 2027
1 package
  • 0002-4503-31 1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE, since Apr 1, 2026
FoundayoOrforglipron0002-4794Tablet, Film Coated · Oral5.5 mgApproved productNDA · NDA220934Since Apr 1, 2026Certified through Dec 31, 2027
1 package
  • 0002-4794-31 1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE, since Apr 1, 2026
FoundayoOrforglipron0002-4803Tablet, Film Coated · Oral9 mgApproved productNDA · NDA220934Since Apr 1, 2026Certified through Dec 31, 2027
1 package
  • 0002-4803-31 1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE, since Apr 1, 2026
FoundayoOrforglipron0002-4839Tablet, Film Coated · Oral14.5 mgApproved productNDA · NDA220934Since Apr 1, 2026Certified through Dec 31, 2027
1 package
  • 0002-4839-31 1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE, since Apr 1, 2026
FoundayoOrforglipron0002-4953Tablet, Film Coated · Oral17.2 mgApproved productNDA · NDA220934Since Apr 1, 2026Certified through Dec 31, 2027
1 package
  • 0002-4953-31 1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE, since Apr 1, 2026
Dulaglutide0002-1401Injection, Solution0.75 mg/0.5 mLUnfinished, for further processingDRUG FOR FURTHER PROCESSINGSince Sep 22, 2014Certified through Dec 31, 2026
1 package
  • 0002-1401-71 9 TRAY in 1 BOX / 160 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE, since Sep 22, 2014
Dulaglutide0002-1402Injection, Solution1.5 mg/0.5 mLUnfinished, for further processingDRUG FOR FURTHER PROCESSINGSince Sep 22, 2014Certified through Dec 31, 2026
1 package
  • 0002-1402-71 9 TRAY in 1 BOX / 160 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE, since Sep 22, 2014
tirzepatide0002-0770Powder1 kg/kgBulk ingredientBULK INGREDIENTSince Jun 20, 2023Certified through Dec 31, 2026
1 package
  • 0002-0770-04 7 kg in 1 DRUM, since Jun 20, 2023

The rest of its federal record

Checked against every GLP-1 record we publish from FDA. A recall or shortage counts when FDA printed one of this firm’s NDCs in it; a letter or 503B entry counts when the firm name matches exactly. Similar names are listed apart and not counted.

503B outsourcing facility register

Not on the register under this name.

GLP-1 recalls

No GLP-1 recall in FDA’s enforcement reports matches this firm.

FDA enforcement reports, updated by FDA Sep 23, 2026. Every GLP-1 recall

FDA drug shortage list

None of this firm’s NDCs is on FDA’s GLP-1 shortage entries.

FDA drug shortages ↗, updated by FDA Oct 2, 2026.

What these listings mean, and what they do not

  • Approved product. A finished product sold under an approved application (NDA, BLA or ANDA). The approval belongs to the application, which Drugs@FDA lists with its holder; the NDC is only the product's identifier.
  • Unfinished, for further processing. Drug made to be processed further by another firm (filled, packed or finished elsewhere), not sold to patients in this form.
  • Bulk ingredient. The active ingredient itself, as powder or solution, sold to manufacturers or, where the listing says so, to compounders. A listing tells FDA the firm makes or sells it; it is not an approval of the ingredient or of anything made from it.

A listing is not an approval, and not a quality check. It tells FDA a firm makes, labels or compounds a drug. Whether a product was approved is a question about its application, shown above where there is one. Whether a plant passed inspection is a different record again.

The molecules. Tirzepatide is the ingredient in Mounjaro, Zepbound; Dulaglutide is the ingredient in Trulicity; Orforglipron is the ingredient in Foundayo.

“Inclusion in the NDC Directory does not indicate that FDA has verified the information provided or that the products are FDA-approved.”FDA, National Drug Code Directory page, confirmed on the page Oct 4, 2026. fda.gov ↗
“Assignment of an NDC number does not in any way denote FDA approval of the product.”FDA, National Drug Code Directory page, confirmed on the page Oct 4, 2026. fda.gov ↗
“A labeler may be a manufacturer, including a repackager or relabeler, or the entity named on the product label.”FDA, National Drug Code Directory page, confirmed on the page Oct 4, 2026. fda.gov ↗
“The content of each NDC Directory entry is the responsibility of the labeler submitting the SPL file.”FDA, National Drug Code Directory page, confirmed on the page Oct 4, 2026. fda.gov ↗

Related records

Other firms listing tirzepatide, dulaglutide and orforglipron

FDA registers on this site

Sources

  • FDA NDC directory via openFDA ↗, updated by FDA .
  • Application holders: Drugs@FDA, updated by FDA Oct 2, 2026.
  • FDA’s National Drug Code Directory page ↗ for the quoted definitions.
  • Read by us Oct 4, 2026. Not medical advice; this page describes filings, not products’ safety.