🇺🇸
United States · US · US:67877-558_2d1f9396-9ea9-423e-811a-75f24523010a
Brompheniramine, Pseudoephedrine, Dextromethorphan
Orange BookUNIISPLATC R06AB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeR06AB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116787755816473 mL in 1 BOTTLE (67877-558-16)
- ndc116787755817118 mL in 1 BOTTLE (67877-558-17)
Annotations
UNII (FDA Substance ID)
IXA7C9ZN03
BROMPHENIRAMINE MALEATE
RxCUI 142427
Orange Book
A210647
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": {
"036b587a-7bfe-4149-bd05-34a37e3e84b6": {
"match": "brand_token",
"title": "BROMPHENIRAMINE, PSEUDOEPHEDRINE, DEXTROMETHORPHAN SYRUP [ASCEND LABORATORIES, LLC]",
"spl_version": "7",
"published_date": "2026-01-06"
}
},
"productid": "67877-558_2d1f9396-9ea9-423e-811a-75f24523010a",
"productndc": "67877-558",
"dosage_form": "SYRUP",
"orange_book": {
"appl_no": "210647",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "2MG/5ML;10MG/5ML;30MG/5ML",
"product_no": "001",
"approval_date": "Jul 14, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "Brompheniramine, Pseudoephedrine, Dextromethorphan",
"active_ingred_unit": "mg/5mL; mg/5mL; mg/5mL",
"application_number": "ANDA210647",
"marketing_category": "ANDA",
"nonproprietary_name": "Brompheniramine, Pseudoephedrine, Dextromethorphan",
"start_marketing_date": "20260105",
"active_numerator_strength": "2; 10; 30"
}Related drugs
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