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United States · US · US:63187-930_57b91c11-72cf-43cb-8e47-eb6345d95653

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide

Orange BookUNIISPLATC R06AB

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeR06AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6318793004
    118 mL in 1 BOTTLE, PLASTIC (63187-930-04)
  • ndc11
    6318793016
    473 mL in 1 BOTTLE, PLASTIC (63187-930-16)

Annotations

UNII (FDA Substance ID)
IXA7C9ZN03
BROMPHENIRAMINE MALEATE
RxCUI 142427
Orange Book
A203375
AA
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": "63187-930_57b91c11-72cf-43cb-8e47-eb6345d95653",
  "productndc": "63187-930",
  "dosage_form": "SYRUP",
  "orange_book": {
    "appl_no": "203375",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "2MG/5ML;10MG/5ML;30MG/5ML",
        "product_no": "001",
        "approval_date": "Sep 20, 2016"
      }
    ],
    "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, Dextromethorphan Hydrobromide",
  "active_ingred_unit": "mg/5mL; mg/5mL; mg/5mL",
  "application_number": "ANDA203375",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide",
  "start_marketing_date": "20160921",
  "active_numerator_strength": "2; 10; 30"
}

Related drugs

Other records sharing ATC code R06AB.

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