🇺🇸
United States · US · US:80425-0215_2a9aa22e-db3d-217b-e063-6294a90a4c41
Butalbital/Acetaminophen/Caffeine
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11804250215130 CAPSULE in 1 BOTTLE (80425-0215-1)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A213321
AA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Acetaminophen; Oxycodone Hydrochloride Tablet
Raw payload (JSON)
{
"unii": {
"unii": "362O9ITL9D",
"rxcui": "161",
"inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
"display_name": "ACETAMINOPHEN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"f16429e2-4944-5bbc-e053-2a95a90ab528": {
"match": "brand_token",
"title": "BUTALBITAL/ACETAMINOPHEN/CAFFEINE CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]",
"spl_version": "3",
"published_date": "2025-01-02"
}
},
"productid": "80425-0215_2a9aa22e-db3d-217b-e063-6294a90a4c41",
"productndc": "80425-0215",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "213321",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "300MG;50MG;40MG",
"product_no": "001",
"approval_date": "Apr 8, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": "CIII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACETAMINOPHEN; BUTALBITAL; CAFFEINE",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "Butalbital/Acetaminophen/Caffeine",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "ANDA213321",
"marketing_category": "ANDA",
"nonproprietary_name": "Butalbital/Acetaminophen/Caffeine",
"start_marketing_date": "20230103",
"active_numerator_strength": "300; 50; 40"
}Related drugs
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