Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide

Orange BookUNIISPLATC R06AB

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeR06AB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6318766404
118 mL in 1 BOTTLE, PLASTIC (63187-664-04)

Annotations

UNII (FDA Substance ID)

IXA7C9ZN03

BROMPHENIRAMINE MALEATE

RxCUI 142427

Orange Book

A205292

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "IXA7C9ZN03",
    "rxcui": "142427",
    "inchikey": "SRGKFVAASLQVBO-BTJKTKAUSA-N",
    "display_name": "BROMPHENIRAMINE MALEATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "8a4b2d13-d1c9-416f-95fd-f7d7b7970bb5": {
      "match": "brand_token",
      "title": "BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, SYRUP [EYWA PHARMA INC]",
      "spl_version": "2",
      "published_date": "2026-05-13"
    }
  },
  "productid": "63187-664_052ce621-5b6e-4246-a510-2673f8fc1503",
  "productndc": "63187-664",
  "dosage_form": "SYRUP",
  "orange_book": {
    "appl_no": "205292",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "2MG/5ML;10MG/5ML;30MG/5ML",
        "product_no": "001",
        "approval_date": "Jul 15, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide",
  "active_ingred_unit": "mg/5mL; mg/5mL; mg/5mL",
  "application_number": "ANDA205292",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide",
  "start_marketing_date": "20150206",
  "active_numerator_strength": "2; 10; 30"
}

Related drugs

Other records sharing ATC code R06AB.

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