dextromethorphan polistirex extended release

Generic: dextromethorphan polistirex

Labeler: bryant ranch prepack
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dextromethorphan polistirex extended release
Generic Name dextromethorphan polistirex
Labeler bryant ranch prepack
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 30 mg/5mL

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 72162-2281
Product ID 72162-2281_af097075-983d-40e4-bf56-88d05d7e15d7
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091135
Listing Expiration 2026-12-31
Marketing Start 2012-09-10

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 721622281
Hyphenated Format 72162-2281

Supplemental Identifiers

RxCUI
1373045
UNII
9D2RTI9KYH

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 ANDA091135 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (72162-2281-2) / 89 mL in 1 BOTTLE
source: ndc

Packages (1)

72162-2281-2 1 BOTTLE in 1 CARTON (72162-2281-2) / 89 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 
{"route": ["ORAL"], "spl_id": "af097075-983d-40e4-bf56-88d05d7e15d7", "openfda": {"unii": ["9D2RTI9KYH"], "rxcui": ["1373045"], "spl_set_id": ["bd415342-90e1-411b-b6c9-652e9532c611"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (72162-2281-2)  / 89 mL in 1 BOTTLE", "package_ndc": "72162-2281-2", "marketing_start_date": "20240430"}], "brand_name": "dextromethorphan polistirex extended release", "product_id": "72162-2281_af097075-983d-40e4-bf56-88d05d7e15d7", "dosage_form": "SUSPENSION", "pharm_class": ["Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "72162-2281", "generic_name": "dextromethorphan polistirex", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN OTC DRUG", "brand_name_base": "dextromethorphan polistirex extended release", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/5mL"}], "application_number": "ANDA091135", "marketing_category": "ANDA", "marketing_start_date": "20120910", "listing_expiration_date": "20261231"}