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United States · US · US:0121-0933_44a05fe1-89fe-4252-b0b8-1ce678a4c6a7

Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide

Orange BookUNIISPLATC R06AB

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

Identification

ManufacturerPAI Holdings, LLC dba PAI Pharma
CountryUS (United States)
ATC codeR06AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0121093304
    118 mL in 1 BOTTLE (0121-0933-04)
  • ndc11
    0121093316
    473 mL in 1 BOTTLE (0121-0933-16)

Annotations

UNII (FDA Substance ID)
IXA7C9ZN03
BROMPHENIRAMINE MALEATE
RxCUI 142427
Orange Book
A202940
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": "0121-0933_44a05fe1-89fe-4252-b0b8-1ce678a4c6a7",
  "productndc": "0121-0933",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "202940",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "2MG/5ML;10MG/5ML;30MG/5ML",
        "product_no": "001",
        "approval_date": "Jul 21, 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": "ANDA202940",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide",
  "start_marketing_date": "20220303",
  "active_numerator_strength": "2; 10; 30"
}

Related drugs

Other records sharing ATC code R06AB.

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