🇺🇸
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
- ndc1168999302242 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"
}Related drugs
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