🇺🇸
United States · US · US:70518-4467_495eb3fc-ff88-fce6-e063-6294a90a8b4c
Butalbital, Acetaminophen and Caffeine
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11705184467020 TABLET in 1 BOTTLE, PLASTIC (70518-4467-0)
- ndc11705184467160 TABLET in 1 BOTTLE, PLASTIC (70518-4467-1)
- ndc11705184467260 TABLET in 1 BOTTLE, PLASTIC (70518-4467-2)
- ndc117051844673180 TABLET in 1 BOTTLE, PLASTIC (70518-4467-3)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A040511
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": "70518-4467_495eb3fc-ff88-fce6-e063-6294a90a8b4c",
"productndc": "70518-4467",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "040511",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "325MG;50MG;40MG",
"product_no": "001",
"approval_date": "Aug 27, 2003"
}
],
"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 and Caffeine",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "ANDA040511",
"marketing_category": "ANDA",
"nonproprietary_name": "Butalbital, Acetaminophen, and Caffeine",
"start_marketing_date": "20250905",
"active_numerator_strength": "325; 50; 40"
}Related drugs
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