🇺🇸
United States · US · US:11534-187_7b8cb532-14e4-4cc6-b799-6855a0c10b14
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSUNRISE PHARMACEUTICAL, INC
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc111153418701100 CAPSULE in 1 BOTTLE (11534-187-01)
- ndc111153418704500 CAPSULE in 1 BOTTLE (11534-187-04)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A207118
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": "11534-187_7b8cb532-14e4-4cc6-b799-6855a0c10b14",
"productndc": "11534-187",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "207118",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "300MG;50MG;40MG",
"product_no": "001",
"approval_date": "Oct 28, 2016"
}
],
"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": "ANDA207118",
"marketing_category": "ANDA",
"nonproprietary_name": "butalbital, acetaminophen and caffeine",
"start_marketing_date": "20170110",
"active_numerator_strength": "300; 50; 40"
}Related drugs
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