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Drug company (FDA labeler)

First Nation Group, LLC

NDC labeler code: 81469

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

17Products (NDC)

FDA applications for these products

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
ApprovedApplicationMedicineSponsor
August 12, 2025ANDA217358 Divalproex sodium
DIVALPROEX SODIUM
Mankind Pharma
April 3, 2025ANDA219291 Bumetanide
BUMETANIDE
Mankind Pharma
March 17, 2025ANDA218196 Bimatoprost
BIMATOPROST
Mankind Pharma
November 1, 2023ANDA217271 Midodrine hydrochloride
MIDODRINE HYDROCHLORIDE
Mankind Pharma
January 11, 2023ANDA216496 Phenylephrine
PHENYLEPHRINE HYDROCHLORIDE
Mankind Pharma
September 29, 2022ANDA216859 Phenylephrine
PHENYLEPHRINE HYDROCHLORIDE
Mankind Pharma
February 9, 2022ANDA215710 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE
Mankind Pharma
September 28, 2009ANDA078771 Timolol
TIMOLOL MALEATE
Mankind Pharma

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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