dextromethorphan polistirex extended-release

Generic: dextromethorphan polistirex

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

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 65162-799
Product ID 65162-799_9eb36122-c3bf-4b04-84a1-bb137f884c40
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 65162799
Hyphenated Format 65162-799

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 (65162-799-76) / 89 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (65162-799-77) / 148 mL in 1 BOTTLE
source: ndc

Packages (2)

65162-799-76 1 BOTTLE in 1 CARTON (65162-799-76) / 89 mL in 1 BOTTLE 65162-799-77 1 BOTTLE in 1 CARTON (65162-799-77) / 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 
{"route": ["ORAL"], "spl_id": "9eb36122-c3bf-4b04-84a1-bb137f884c40", "openfda": {"unii": ["9D2RTI9KYH"], "rxcui": ["1373045"], "spl_set_id": ["e0104a59-0bc2-4401-8c14-7f28499dbac6"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65162-799-76)  / 89 mL in 1 BOTTLE", "package_ndc": "65162-799-76", "marketing_start_date": "20170801"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (65162-799-77)  / 148 mL in 1 BOTTLE", "package_ndc": "65162-799-77", "marketing_start_date": "20170801"}], "brand_name": "Dextromethorphan Polistirex Extended-Release", "product_id": "65162-799_9eb36122-c3bf-4b04-84a1-bb137f884c40", "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": "65162-799", "generic_name": "Dextromethorphan Polistirex", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dextromethorphan Polistirex Extended-Release", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/5mL"}], "application_number": "ANDA203133", "marketing_category": "ANDA", "marketing_start_date": "20170801", "listing_expiration_date": "20261231"}