🇺🇸
United States · US · US:72189-600_34a42e66-3892-4594-e063-6294a90a7f6b
BUTAL/APAP/CAFFEINE
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDirect_Rx
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11721896001212 TABLET in 1 BOTTLE (72189-600-12)
- ndc11721896003030 TABLET in 1 BOTTLE (72189-600-30)
- ndc11721896006060 TABLET in 1 BOTTLE (72189-600-60)
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": {
"2abb9915-edb2-6218-e063-6394a90ad462": {
"match": "brand_token",
"title": "BUTAL/APAP/CAFFEINE TABLET [DIRECT_RX]",
"spl_version": "4",
"published_date": "2025-05-12"
}
},
"productid": "72189-600_34a42e66-3892-4594-e063-6294a90a7f6b",
"productndc": "72189-600",
"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": "BUTAL/APAP/CAFFEINE",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "ANDA209587",
"marketing_category": "ANDA",
"nonproprietary_name": "BUTAL/APAP/CAFFEINE",
"start_marketing_date": "20250102",
"active_numerator_strength": "325; 50; 40"
}Related drugs
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- 🇺🇸Acetaminophen , Caffeine and pyrilamine maleateSoftgel Healthcare Pvt Ltd
- 🇺🇸Acetaminophen 250 mg and Ibuprofen 125 mgR J General Corporation
- 🇺🇸Acetaminophen 250 mg and Ibuprofen 125 mgSun Pharmaceutical Industries, Inc.
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