dextromethorphan polistirex extended release (45802-433)

Drug Facts

Product Profile

Brand Name dextromethorphan polistirex extended release

Generic Name dextromethorphan polistirex

Labeler padagis israel pharmaceuticals ltd

Dosage Form SUSPENSION

Routes

ORAL

Active Ingredients

dextromethorphan hydrobromide 30 mg/5mL

Manufacturer

Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-433

Product ID 45802-433_089bd748-c172-48a7-932a-f96ad7b0515a

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 45802433

Hyphenated Format 45802-433

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 ANDA091135 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

30 mg/5mL

source: ndc

Packaging

1 BOTTLE in 1 CARTON (45802-433-21) / 89 mL in 1 BOTTLE

source: ndc

Packages (1)

45802-433-21 1 BOTTLE in 1 CARTON (45802-433-21) / 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": "089bd748-c172-48a7-932a-f96ad7b0515a", "openfda": {"unii": ["9D2RTI9KYH"], "rxcui": ["1373045"], "spl_set_id": ["7a6b68eb-8fe0-447d-aed7-28432c45b58c"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (45802-433-21)  / 89 mL in 1 BOTTLE", "package_ndc": "45802-433-21", "marketing_start_date": "20120910"}], "brand_name": "dextromethorphan polistirex extended release", "product_id": "45802-433_089bd748-c172-48a7-932a-f96ad7b0515a", "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": "45802-433", "generic_name": "dextromethorphan polistirex", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "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"}