🇺🇸
United States · US · US:81005-123_37ca06ac-1f37-4952-e063-6394a90a2a0e
BUTALBITAL AND ACETAMINOPHEN
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAarkish Pharmaceuticals NJ Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc118100512301100 TABLET in 1 BOTTLE (81005-123-01)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A214955
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": {
"3280501f-928a-4112-803d-fb9771c86547": {
"match": "brand_token",
"title": "BUTALBITAL AND ACETAMINOPHEN TABLET [AMICI PHARMA, INC.]",
"spl_version": "1",
"published_date": "2026-03-23"
}
},
"productid": "81005-123_37ca06ac-1f37-4952-e063-6394a90a2a0e",
"productndc": "81005-123",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "214955",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "300MG;50MG",
"product_no": "001",
"approval_date": "Aug 16, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": "CIII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACETAMINOPHEN; BUTALBITAL",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "BUTALBITAL AND ACETAMINOPHEN",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA214955",
"marketing_category": "ANDA",
"nonproprietary_name": "butalbital and acetaminophen",
"start_marketing_date": "20241203",
"active_numerator_strength": "300; 50"
}Related drugs
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