🇺🇸
United States · US · US:0054-3000_3477a730-97ec-460b-9e7f-0fd5e84c4404
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110054300001100 CAPSULE in 1 BOTTLE (0054-3000-01)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A215138
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": {
"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": "0054-3000_3477a730-97ec-460b-9e7f-0fd5e84c4404",
"productndc": "0054-3000",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "215138",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "325MG;50MG;40MG;30MG",
"product_no": "001",
"approval_date": "Jan 26, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG;50MG;40MG;30MG",
"product_no": "002",
"approval_date": "Jan 26, 2022"
}
],
"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": "Butalbital, Acetaminophen, Caffeine and Codeine Phosphate",
"active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
"application_number": "ANDA215138",
"marketing_category": "ANDA",
"nonproprietary_name": "Butalbital, Acetaminophen, Caffeine and Codeine Phosphate",
"start_marketing_date": "20220509",
"active_numerator_strength": "325; 50; 40; 30"
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