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Drug company (FDA labeler)

Amici Pharmaceuticals LLC

Name in FDA records: AMICI PHARMACEUTICALS LLC

NDC labeler code: 69292

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

14Products (NDC)

FDA applications for these products

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
ApprovedApplicationMedicineSponsor
May 18, 2022ANDA210568 Cefpodoxime proxetil
CEFPODOXIME PROXETIL
Alkem Labs Ltd
December 22, 2004ANDA076963 Pilocarpine hydrochloride
PILOCARPINE HYDROCHLORIDE
Innogenix
January 7, 1988ANDA071173 Haloperidol
HALOPERIDOL
Sciegen Pharms
August 4, 1986ANDA070322 Propranolol hydrochloride
PROPRANOLOL HYDROCHLORIDE
Innogenix

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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