🇺🇸
United States · US · US:43547-686_f0520093-dfda-4a04-85c4-9ef3c23a8b60
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSOLCO HEALTHCARE US, LLC
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc114354768610100 CAPSULE in 1 BOTTLE (43547-686-10)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A214087
AAAA
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": "43547-686_f0520093-dfda-4a04-85c4-9ef3c23a8b60",
"productndc": "43547-686",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "214087",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "300MG;50MG;40MG",
"product_no": "001",
"approval_date": "Aug 13, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;50MG;40MG",
"product_no": "002",
"approval_date": "Aug 13, 2021"
}
],
"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": "ANDA214087",
"marketing_category": "ANDA",
"nonproprietary_name": "butalbital, acetaminophen and caffeine",
"start_marketing_date": "20231205",
"active_numerator_strength": "300; 50; 40"
}Related drugs
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