brompheniramine, pseudoephedrine, dextromethorphan (67877-558)

Drug Facts

Product Profile

Brand Name brompheniramine, pseudoephedrine, dextromethorphan

Generic Name brompheniramine, pseudoephedrine, dextromethorphan

Labeler ascend laboratories, llc

Dosage Form SYRUP

Routes

ORAL

Active Ingredients

brompheniramine maleate 2 mg/5mL, dextromethorphan hydrobromide 10 mg/5mL, pseudoephedrine hydrochloride 30 mg/5mL

Manufacturer

Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-558

Product ID 67877-558_2d1f9396-9ea9-423e-811a-75f24523010a

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA210647

Listing Expiration 2027-12-31

Marketing Start 2026-01-05

Pharmacologic Class

Classes

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877558

Hyphenated Format 67877-558

Supplemental Identifiers

RxCUI

1357010

UPC

0367877558172

UNII

IXA7C9ZN03 9D2RTI9KYH 6V9V2RYJ8N

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 brompheniramine, pseudoephedrine, dextromethorphan (source: ndc)

Generic Name brompheniramine, pseudoephedrine, dextromethorphan (source: ndc)

Application Number ANDA210647 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

2 mg/5mL
10 mg/5mL
30 mg/5mL

source: ndc

Packaging

473 mL in 1 BOTTLE (67877-558-16)
118 mL in 1 BOTTLE (67877-558-17)

source: ndc

Packages (2)

67877-558-16 473 mL in 1 BOTTLE (67877-558-16) 67877-558-17 118 mL in 1 BOTTLE (67877-558-17)

Ingredients (3)

brompheniramine maleate (2 mg/5mL) dextromethorphan hydrobromide (10 mg/5mL) pseudoephedrine hydrochloride (30 mg/5mL)

Linked Drug Pages (1)

Brompheniramine, Pseudoephedrine, Dextromethorphan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "2d1f9396-9ea9-423e-811a-75f24523010a", "openfda": {"upc": ["0367877558172"], "unii": ["IXA7C9ZN03", "9D2RTI9KYH", "6V9V2RYJ8N"], "rxcui": ["1357010"], "spl_set_id": ["036b587a-7bfe-4149-bd05-34a37e3e84b6"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (67877-558-16)", "package_ndc": "67877-558-16", "marketing_start_date": "20260105"}, {"sample": false, "description": "118 mL in 1 BOTTLE (67877-558-17)", "package_ndc": "67877-558-17", "marketing_start_date": "20260105"}], "brand_name": "Brompheniramine, Pseudoephedrine, Dextromethorphan", "product_id": "67877-558_2d1f9396-9ea9-423e-811a-75f24523010a", "dosage_form": "SYRUP", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "67877-558", "generic_name": "Brompheniramine, Pseudoephedrine, Dextromethorphan", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Brompheniramine, Pseudoephedrine, Dextromethorphan", "active_ingredients": [{"name": "BROMPHENIRAMINE MALEATE", "strength": "2 mg/5mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "30 mg/5mL"}], "application_number": "ANDA210647", "marketing_category": "ANDA", "marketing_start_date": "20260105", "listing_expiration_date": "20271231"}