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NDC 65162-0700-77 Dextromethorphan Polistirex Extended-Release 30 mg/5mL Details

Dextromethorphan Polistirex Extended-Release 30 mg/5mL

Dextromethorphan Polistirex Extended-Release is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is DEXTROMETHORPHAN HYDROBROMIDE.

MedlinePlus Drug Summary

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 65162-0700-77
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan

Product Information

NDC	65162-0700
Product ID	65162-700_5fb00cff-beb5-4df6-b9d4-f697310f4508
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Dextromethorphan Polistirex Extended-Release
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dextromethorphan Polistirex
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	30
Active Ingredient Units	mg/5mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE
Labeler Name	Amneal Pharmaceuticals LLC
Pharmaceutical Class	Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA203133
Listing Certified Through	2024-12-31

Package

NDC 65162-0700-77 (65162070077)

Pricing Information	N/A
NDC Package Code	65162-700-77
Billing NDC	65162070077
Package	1 BOTTLE in 1 CARTON (65162-700-77) / 148 mL in 1 BOTTLE
Marketing Start Date	2017-08-01
NDC Exclude Flag	N