🇺🇸
United States · US · US:0591-2641_423a1275-8347-42e4-82b9-bd4f193c03e6
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
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 · 1
- ndc110591264101100 CAPSULE in 1 BOTTLE, PLASTIC (0591-2641-01)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A076560
ABAB
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": "0591-2641_423a1275-8347-42e4-82b9-bd4f193c03e6",
"productndc": "0591-2641",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "076560",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "325MG;50MG;40MG;30MG",
"product_no": "001",
"approval_date": "Jun 10, 2004"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG;50MG;40MG;30MG",
"product_no": "002",
"approval_date": "Jul 19, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": "CIII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate",
"active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
"application_number": "ANDA076560",
"marketing_category": "ANDA",
"nonproprietary_name": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate",
"start_marketing_date": "20130729",
"active_numerator_strength": "300; 50; 40; 30"
}Related drugs
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