Guaifenesin and Dextromethorphan HBr

NDC 65162-039 · Amneal Pharmaceuticals LLC

Generic nameGuaifenesin and Dextromethorphan HBr

Dosage formTABLET, EXTENDED RELEASE

RouteORAL

Active ingredient(s)GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE

Strength60; 1200 mg/1; mg/1

Pharmacologic classDecreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]

Marketing categoryANDA

Packages

65162-039-03 — 1 BOTTLE in 1 CARTON (65162-039-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE

65162-039-06 — 1 BOTTLE in 1 CARTON (65162-039-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE

65162-039-17 — 2 BLISTER PACK in 1 CARTON (65162-039-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

65131-101 — Acetaminophen-Dextromethorphan HBr-Phenylephrine HCl-Chlorpheniramine Maleate, 65131-109 — ACETAMINOPHEN-PHENYLEPHRINE HCl-GUAIFENESIN, 65131-110 — DEXTROMETHORPHAN HBR-PYRILAMINE MALEATE, 65131-111 — Acetaminophen-Dextromethorphan HBr-Phenylephrine HCl-Chlorpheniramine Maleate, 65131-116 — ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBr-GUAIFENESIN-PHENYLEPHRINE HCl, 65131-180 — DEXTROMETHORPHAN HBr-GUAIFENESIN, 65131-418 — Chlorpheniramine maleate-Dextromethrophan HBr, 65162-036 — Guaifenesin, 65162-037 — Guaifenesin, 65162-038 — Guaifenesin and Dextromethorphan HBr, 65162-680 — Promethazine Hydrochloride and Dextromethorphan Hydrobromide, 65162-700 — Dextromethorphan Polistirex, 65162-799 — Dextromethorphan Polistirex, 65852-002 — Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCL, 65852-003 — Dextromethorphan HBr, Guaifenesin, 65852-004 — Dextromethorphan HBr, 65852-005 — Dextromethorphan HBr, Guaifenesin, 65852-006 — Dextromethorphan hydrobromide, Guaifenesin, 65852-007 — Dextromethorphan HBr, 65852-008 — Guaifenesin, +2508 more

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