PriceTracker GLP-1

What FDA’s records state

FDA listing summary for Hikma Pharmaceuticals USA Inc.
FieldWhat FDA’s record statesSource
Firm, as FDA lists itHikma Pharmaceuticals USA Inc.openFDA NDC
Also listed asNo other spellingopenFDA NDC
FDA labeler code0143openFDA NDC
MoleculesLiraglutideopenFDA NDC
Kinds of listingApproved product: 1openFDA NDC
Products and packages1 product, 2 package NDCsopenFDA NDC
Earliest listing dateDec 24, 2024openFDA NDC
Latest listing dateDec 24, 2024openFDA NDC
Approved applications citedANDA215503 (LIRAGLUTIDE), held by HIKMA, first approved Dec 23, 2024Drugs@FDA

Every GLP-1 product Hikma Pharmaceuticals USA Inc. 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 Hikma Pharmaceuticals USA Inc.
ProductProduct NDCForm and strengthFDA categoryListedPackages
Liraglutide0143-9144Injection · Subcutaneous6 mg/mLApproved productANDA · ANDA215503Since Dec 24, 2024Certified through Dec 31, 2027
2 packages
  • 0143-9144-02 2 SYRINGE, PLASTIC in 1 CARTON / 3 mL in 1 SYRINGE, PLASTIC, since Dec 24, 2024
  • 0143-9144-03 3 SYRINGE, PLASTIC in 1 CARTON / 3 mL in 1 SYRINGE, PLASTIC, since Dec 24, 2024

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 warning letters

None of the GLP-1 warning letters we hold is addressed to 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

  • Current: Liraglutide, Injection, 6 mg/1 mL (NDC 0143-9144-02)Hikma Pharmaceuticals USA, Inc. · FDA updated Sep 18, 2026
  • Current: Liraglutide, Injection, 6 mg/1 mL (NDC 0143-9144-03)Hikma Pharmaceuticals USA, Inc. · FDA updated Sep 18, 2026

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.

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. Liraglutide is the ingredient in Victoza, Saxenda.

“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 liraglutide

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.