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Drug company (FDA labeler)

BE Pharmaceuticals Inc.

NDC labeler code: 71839

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

29Products (NDC)

Prescription medicines

FDA applications for these products

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
ApprovedApplicationMedicineSponsor
June 4, 2026ANDA219604 Dalbavancin
DALBAVANCIN HYDROCHLORIDE
Be Pharms
September 15, 2023ANDA217575 Norepinephrine bitartrate
NOREPINEPHRINE BITARTRATE
Caplin
June 26, 2023ANDA217521 Phenylephrine
PHENYLEPHRINE HYDROCHLORIDE
Be Pharms
June 6, 2023ANDA214646 Enoxaparin sodium
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Be Pharms
March 2, 2023ANDA216234 Rocuronium bromide
ROCURONIUM BROMIDE
Caplin
February 13, 2023ANDA216882 Carboprost tromethamine
CARBOPROST TROMETHAMINE
Caplin
May 18, 2022ANDA216171 Pantoprazole sodium
PANTOPRAZOLE SODIUM
Be Pharms
February 7, 2022ANDA216003 Succinylcholine
SUCCINYLCHOLINE CHLORIDE
Be Pharms
July 12, 2021ANDA214971 Sodium nitroprusside
SODIUM NITROPRUSSIDE
Be Pharms
December 29, 2020ANDA214804 Heparin sodium
HEPARIN SODIUM
Be Pharms
December 29, 2020ANDA214839 Heparin sodium
HEPARIN SODIUM
Be Pharms
August 20, 2020ANDA213425 Daptomycin
DAPTOMYCIN
Be Pharms
September 5, 2019ANDA212309 Fosaprepitant
FOSAPREPITANT DIMEGLUMINE
Be Pharms
June 26, 2019ANDA212513 Daptomycin
DAPTOMYCIN
Be Pharms
May 13, 2019ANDA212512 Neostigmine methylsulfate
NEOSTIGMINE METHYLSULFATE
Be Pharms
March 20, 2019ANDA211705 Glycopyrrolate
GLYCOPYRROLATE
Caplin

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

Recall timeline

2024

  1. January 10, 2024 · Class II · Terminated · D-0262-2024 · Fosaprepitant

    Lack of Sterility Assurance: Aseptic process simulation failure.

    Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single Dose Vial, Rx Only, Distributed by BE Pharmaceuticals Inc. 203 New Edition Court

2023

  1. September 5, 2023 · Class II · Terminated · D-1148-2023 · Pantoprazole sodium

    Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.

    Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-10; (b) 25 Single-dose vials, NDC 71839-122-25; Rx Only, Mfd. in India for and Distr

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

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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