🇺🇸
United States · US · US:63629-2303_44e02320-4dfa-4ebb-aa60-0bb4c094c103
Hydrocodone Polistirex and Chlorpheniramine Polistirex
Orange BookUNIISPLATC R06AB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeR06AB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163629230311 BOTTLE, UNIT-DOSE in 1 CARTON (63629-2303-1) / 115 mL in 1 BOTTLE, UNIT-DOSE
Annotations
UNII (FDA Substance ID)
V1Q0O9OJ9Z
CHLORPHENIRAMINE MALEATE
RxCUI 142429
Orange Book
A091632
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "V1Q0O9OJ9Z",
"rxcui": "142429",
"inchikey": "DBAKFASWICGISY-BTJKTKAUSA-N",
"display_name": "CHLORPHENIRAMINE MALEATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"1f9c1adc-f84f-43de-af5c-d93703aba7f8": {
"match": "brand_token",
"title": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RHODES PHARMACEUTICALS LLC]",
"spl_version": "20",
"published_date": "2026-06-01"
}
},
"productid": "63629-2303_44e02320-4dfa-4ebb-aa60-0bb4c094c103",
"productndc": "63629-2303",
"dosage_form": "SUSPENSION, EXTENDED RELEASE",
"orange_book": {
"appl_no": "091632",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML",
"product_no": "001",
"approval_date": "Oct 1, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE",
"proprietary_name": "Hydrocodone Polistirex and Chlorpheniramine Polistirex",
"active_ingred_unit": "mg/5mL; mg/5mL",
"application_number": "ANDA091632",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydrocodone Polistirex and Chlorpheniramine Polistirex",
"start_marketing_date": "20150306",
"active_numerator_strength": "8; 10"
}Related drugs
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