United States · FDA National Drug Code directory

Hydrocodone Bitartrate and Acetaminophen

A source-listed medicine record.

Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.

Medicine identity

Source reference: 43386-358_2cb73d19-0ef9-4d59-a2de-b7b2b3a369a1
Product NDC: 43386-358
Form: TABLET
Composition / generic term: Hydrocodone Bitartrate and Acetaminophen
Labeler: Lupin Pharmaceuticals,Inc.
Marketing category: ANDA
Marketing start / end (source format): 20161201
Source listing expiry: 20261231

Source-listed ingredients

HYDROCODONE BITARTRATE — 10 mg/1
ACETAMINOPHEN — 325 mg/1

These values do not establish equivalence or a dose recommendation.

Packages

100 TABLET in 1 BOTTLE (43386-358-01) · 43386-358-01
500 TABLET in 1 BOTTLE (43386-358-05) · 43386-358-05
1000 TABLET in 1 BOTTLE (43386-358-10) · 43386-358-10

Source and coverage

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Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.

Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.

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