dextromethorphan polistirex extended-release (65162-700)

Drug Facts

Product Profile

Brand Name dextromethorphan polistirex extended-release

Generic Name dextromethorphan polistirex

Labeler amneal pharmaceuticals llc

Dosage Form SUSPENSION

Routes

ORAL

Active Ingredients

dextromethorphan hydrobromide 30 mg/5mL

Manufacturer

Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-700

Product ID 65162-700_df1662fe-6e62-4093-a047-654e3b700ab3

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA203133

Listing Expiration 2026-12-31

Marketing Start 2017-08-01

Pharmacologic Class

Classes

sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162700

Hyphenated Format 65162-700

Supplemental Identifiers

RxCUI

1373045

UNII

9D2RTI9KYH

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dextromethorphan polistirex extended-release (source: ndc)

Generic Name dextromethorphan polistirex (source: ndc)

Application Number ANDA203133 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

30 mg/5mL

source: ndc

Packaging

1 BOTTLE in 1 CARTON (65162-700-76) / 89 mL in 1 BOTTLE
1 BOTTLE in 1 CARTON (65162-700-77) / 148 mL in 1 BOTTLE

source: ndc

Packages (2)

65162-700-76 1 BOTTLE in 1 CARTON (65162-700-76) / 89 mL in 1 BOTTLE 65162-700-77 1 BOTTLE in 1 CARTON (65162-700-77) / 148 mL in 1 BOTTLE

Ingredients (1)

dextromethorphan hydrobromide (30 mg/5mL)

Linked Drug Pages (1)

Dextromethorphan Polistirex Extended-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

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