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Hydrocodone Bitartrate and Acetaminophen

NDC 53746-109 · Amneal Pharmaceuticals of New York LLC

Generic nameHydrocodone Bitartrate and Acetaminophen
Dosage formTABLET
RouteORAL
Active ingredient(s)HYDROCODONE BITARTRATE, ACETAMINOPHEN
Strength325; 5 mg/1; mg/1
Pharmacologic classOpioid Agonist [EPC], Opioid Agonists [MoA]
DEA scheduleCII
Marketing categoryANDA

Packages

53746-109-01 — 100 TABLET in 1 BOTTLE (53746-109-01)

53746-109-05 — 500 TABLET in 1 BOTTLE (53746-109-05)

53746-109-10 — 1000 TABLET in 1 BOTTLE (53746-109-10)

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

53345-020 — acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride, 53345-021 — acetaminophen, dextromethorphan hydrobromide, Guaifenesin, phenylephrine hydrochloride, 53345-025 — acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, 53345-026 — acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, 53345-030 — acetaminophen, phenylephrine hydrochloride, 53345-031 — Acetaminophen, Doxylamine succinate, Phenylephrine hydrochloride, 53345-045 — Acetaminophen, Phenylephrine HCl, Chlorpheniramine Maleate, Dextromethorphan HBr, 53345-052 — acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, 53345-053 — acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride, 53345-056 — Acetaminophen and Dextromethorphan hydrobromide, 53746-110 — Hydrocodone Bitartrate and Acetaminophen, 53746-116 — Hydrocodone Bitartrate and Ibuprofen, 53746-117 — Hydrocodone Bitartrate and Ibuprofen, 53746-145 — Hydrocodone Bitartrate and Ibuprofen, 53746-146 — Hydrocodone Bitartrate and Ibuprofen, 53746-203 — Oxycodone and Acetaminophen, 53746-204 — Oxycodone and Acetaminophen, 53746-617 — Tramadol Hydrochloride and Acetaminophen, 53942-092 — Acetaminophen, 53942-101 — Acetaminophen, +3514 more

From the FDA National Drug Code Directory, retrieved August 24, 2026. Product listings are submitted by labelers; FDA does not verify them.