🇺🇸
United States · US · US:70518-4309_47bc3bae-b49e-c2b8-e063-6294a90a455f
Butalbital, Acetaminophen, 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 · 2
- ndc117051843090100 TABLET in 1 BOTTLE, PLASTIC (70518-4309-0)
- ndc11705184309160 TABLET in 1 BOTTLE, PLASTIC (70518-4309-1)
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": "70518-4309_47bc3bae-b49e-c2b8-e063-6294a90a455f",
"productndc": "70518-4309",
"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": "20250314",
"active_numerator_strength": "325; 50; 40"
}Related drugs
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