🇺🇸
United States · US · US:52544-082_c5c3390f-a64b-49cb-8fcb-5762dc8ee74a
Fioricet with Codeine
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
- ndc115254408201100 CAPSULE in 1 BOTTLE, PLASTIC (52544-082-01)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A076560
ABAB
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": "52544-082_c5c3390f-a64b-49cb-8fcb-5762dc8ee74a",
"productndc": "52544-082",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "076560",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "325MG;50MG;40MG;30MG",
"product_no": "001",
"approval_date": "Jun 10, 2004"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG;50MG;40MG;30MG",
"product_no": "002",
"approval_date": "Jul 19, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": "CIII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "Fioricet with Codeine",
"active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
"application_number": "ANDA076560",
"marketing_category": "ANDA",
"nonproprietary_name": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate",
"start_marketing_date": "20130729",
"active_numerator_strength": "300; 50; 40; 30"
}Related drugs
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