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
43386-353_cc982f78-de8c-4384-9f43-ffad4169abdd
Product NDC
43386-353
Form
TABLET
Composition / generic term
Hydrocodone Bitartrate and Acetaminophen
Labeler
Lupin Pharmaceuticals,Inc.
Marketing category
ANDA
Marketing start / end (source format)
20161114
Source listing expiry
20261231

Source-listed ingredients

  • HYDROCODONE BITARTRATE — 10 mg/1
  • ACETAMINOPHEN — 300 mg/1

These values do not establish equivalence or a dose recommendation.

Packages

  • 100 TABLET in 1 BOTTLE (43386-353-01) · 43386-353-01
  • 500 TABLET in 1 BOTTLE (43386-353-05) · 43386-353-05

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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