🇺🇸
United States · US · US:0527-4095_146b5639-6699-471c-ae28-1f576bbead9f
Butalbital, Acetaminophen, and Caffeine
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLannett Company, Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110527409537100 CAPSULE in 1 BOTTLE (0527-4095-37)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A212082
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": "0527-4095_146b5639-6699-471c-ae28-1f576bbead9f",
"productndc": "0527-4095",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "212082",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "300MG;50MG;40MG",
"product_no": "001",
"approval_date": "Dec 17, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"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": "ANDA212082",
"marketing_category": "ANDA",
"nonproprietary_name": "Butalbital, Acetaminophen, and Caffeine Capsules",
"start_marketing_date": "20191217",
"active_numerator_strength": "300; 50; 40"
}Related drugs
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