🇺🇸
United States · US · US:76420-802_44818491-48a2-ba4d-e063-6394a90a65f9
Butalbital, Acetaminophen, Caffeine
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 8
- ndc117642080201100 TABLET in 1 BOTTLE (76420-802-01)
- ndc117642080205500 TABLET in 1 BOTTLE (76420-802-05)
- ndc11764208021010 TABLET in 1 BOTTLE (76420-802-10)
- ndc11764208021212 TABLET in 1 BOTTLE (76420-802-12)
- ndc11764208022020 TABLET in 1 BOTTLE (76420-802-20)
- ndc11764208023030 TABLET in 1 BOTTLE (76420-802-30)
- ndc11764208026060 TABLET in 1 BOTTLE (76420-802-60)
- ndc11764208029090 TABLET in 1 BOTTLE (76420-802-90)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A209587
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": "76420-802_44818491-48a2-ba4d-e063-6394a90a65f9",
"productndc": "76420-802",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "209587",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;50MG;40MG",
"product_no": "001",
"approval_date": "Oct 31, 2018"
}
],
"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": "ANDA209587",
"marketing_category": "ANDA",
"nonproprietary_name": "Butalbital, Acetaminophen, and Caffeine",
"start_marketing_date": "20190305",
"active_numerator_strength": "325; 50; 40"
}Related drugs
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