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Guaifenesin and Dextromethorphan HBr

NDC 65162-039, Guaifenesin and Dextromethorphan HBr, tablet, extended release, from Amneal Pharmaceuticals LLC.

Product NDC
65162-039
Status
Listed
Labeler
Amneal Pharmaceuticals LLC
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Product type
HUMAN OTC DRUG
Marketing category
ANDA
Application
ANDA209692
DEA schedule
None
Request
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Product

Active ingredients and packages

Active ingredients

  • GUAIFENESIN1200 mg/1
  • DEXTROMETHORPHAN HYDROBROMIDE60 mg/1

Pharmacologic classes

Decreased 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]

Package NDCNDC-11Package
65162-039-03651620039031 BOTTLE in 1 CARTON (65162-039-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE
65162-039-06651620039061 BOTTLE in 1 CARTON (65162-039-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE
65162-039-17651620039172 BLISTER PACK in 1 CARTON (65162-039-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Linked data

RxNorm, label and prices

RxNorm concepts

Related lookups

No FDA label, Medicare Part B payment limit or NADAC price is linked to this product.

Use it

Look up 65162-039 from code or an agent

curl
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  -H "Authorization: Bearer $HDEV_API_KEY"
MCP prompt
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Source: FDA, release 2026-10-23. Public domain. Reference data, not medical advice.