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United States · US · US:68999-302_4472f94a-77ad-02c3-e063-6294a90a9cf6

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide

Orange BookUNIISPLATC R06AB

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

Identification

ManufacturerChartwell Governmental & Specialty RX, LLC
CountryUS (United States)
ATC codeR06AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6899930224
    2 TRAY in 1 BOX (68999-302-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-302-05)

Annotations

UNII (FDA Substance ID)
IXA7C9ZN03
BROMPHENIRAMINE MALEATE
RxCUI 142427
Orange Book
A213125
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": "68999-302_4472f94a-77ad-02c3-e063-6294a90a9cf6",
  "productndc": "68999-302",
  "dosage_form": "SYRUP",
  "orange_book": {
    "appl_no": "213125",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "2MG/5ML;10MG/5ML;30MG/5ML",
        "product_no": "001",
        "approval_date": "Apr 17, 2020"
      }
    ],
    "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": "ANDA213125",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide",
  "start_marketing_date": "20200417",
  "active_numerator_strength": "2; 10; 30"
}

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