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Drug company (FDA labeler)

Eywa Pharma Inc

NDC labeler code: 71930

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

30Products (NDC)

FDA applications for these products

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
ApprovedApplicationMedicineSponsor
February 10, 2026ANDA220308 Fludrocortisone acetate
FLUDROCORTISONE ACETATE
Adaptis
November 25, 2024ANDA217160 Hydrocortisone
HYDROCORTISONE
Adaptis
September 17, 2021ANDA212589 Quinidine
QUINIDINE GLUCONATE
Adaptis
June 16, 2020ANDA211170 Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Adaptis
October 18, 2019ANDA211556 Acetazolamide
ACETAZOLAMIDE
Adaptis
September 16, 2019ANDA211621 Alosetron hydrochloride
ALOSETRON HYDROCHLORIDE
Adaptis
June 27, 2019ANDA211610 Acetaminophen and codeine phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATE
Adaptis
March 8, 2019ANDA211023 Hydrocodone bitartrate and acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Wes Pharma Inc
February 1, 2019ANDA211555 Baclofen
BACLOFEN
Adaptis
October 29, 2018ANDA207509 Hydrocodone bitartrate and acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Adaptis
October 3, 2018ANDA210139 Methylphenidate
METHYLPHENIDATE HYDROCHLORIDE
Adaptis
March 21, 2018ANDA207510 Oxycodone and acetaminophen
OXYCODONE AND ACETAMINOPHEN
Wes Pharma Inc
October 30, 2017ANDA210211 Hydrocodone bitartrate and acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Wes Pharma Inc
September 6, 2017ANDA209897 Oxycodone hydrochloride
OXYCODONE HYDROCHLORIDE
Adaptis
November 23, 2016ANDA207511 Oxycodone hydrochloride
OXYCODONE HYDROCHLORIDE
Adaptis

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

Recall timeline

2021

  1. March 15, 2021 · Class II · Terminated · D-0474-2021 · Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP 10-30-2MG/5ML 473ML; NDC/UPC 71930-026-43; RX; SYRUP

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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