🇺🇸
United States · US · US:0591-3369_4f43a8e6-42b9-4743-9ffa-3783e1b5e15b
Butalbital, Acetaminophen, and Caffeine
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc110591336901100 TABLET in 1 BOTTLE (0591-3369-01)
- ndc110591336905500 TABLET in 1 BOTTLE (0591-3369-05)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A088616
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": {
"95a33c9b-79a6-47c7-8433-fc217950b88f": {
"match": "brand_token",
"title": "BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]",
"spl_version": "16",
"published_date": "2026-05-28"
}
},
"productid": "0591-3369_4f43a8e6-42b9-4743-9ffa-3783e1b5e15b",
"productndc": "0591-3369",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "088616",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AA",
"strength": "325MG;50MG;40MG",
"product_no": "001",
"approval_date": "Nov 9, 1984"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACETAMINOPHEN; BUTALBITAL; CAFFEINE",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "Butalbital, Acetaminophen, and Caffeine",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "ANDA088616",
"marketing_category": "ANDA",
"nonproprietary_name": "Butalbital, Acetaminophen, and Caffeine",
"start_marketing_date": "20071213",
"active_numerator_strength": "325; 50; 40"
}Related drugs
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