🇺🇸
United States · US · US:52544-080_b31b5178-c2d3-4d0c-9e68-95acc212a74a
Fioricet
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115254408001100 CAPSULE in 1 BOTTLE (52544-080-01)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A040885
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": {
"c018be7d-f7b8-45e2-97b8-8e7a71740657": {
"match": "brand_token",
"title": "FIORICET (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [ACTAVIS PHARMA, INC.]",
"spl_version": "11",
"published_date": "2025-12-11"
}
},
"productid": "52544-080_b31b5178-c2d3-4d0c-9e68-95acc212a74a",
"productndc": "52544-080",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "040885",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "300MG;50MG;40MG",
"product_no": "001",
"approval_date": "Nov 16, 2009"
}
],
"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": "Fioricet",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "ANDA040885",
"marketing_category": "ANDA",
"nonproprietary_name": "Butalbital, Acetaminophen, and Caffeine",
"start_marketing_date": "20130729",
"active_numerator_strength": "300; 50; 40"
}Related drugs
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