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Drug company (FDA labeler)

GSMS, Incorporated

NDC labeler codes: 51407, 84677

What is a labeler?

The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.

Official FDA data only

Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.

Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.

At a glance

11Products (NDC)

Prescription medicines

FDA applications for these products

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
ApprovedApplicationMedicineSponsor
January 22, 2021ANDA210165 Pioglitazone
PIOGLITAZONE HYDROCHLORIDE
Solgen
June 20, 2008ANDA079116 Ramipril
RAMIPRIL
Solgen
May 23, 2007ANDA076719 Amlodipine
AMLODIPINE BESYLATE
Macleods Pharms
October 5, 2004ANDA076674 Lisinopril and hydrochlorothiazide
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Macleods Pharms

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

No recall of these products (by NDC code) appears in the FDA enforcement reports.

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

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