🇺🇸
United States · US · US:25000-080_38a01bed-7a8b-4aed-97c1-cc1545f76f79
Acetaminophen 250 mg and Ibuprofen 125 mg
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMARKSANS PHARMA LIMITED
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1125000080071 BOTTLE in 1 CARTON (25000-080-07) / 90 TABLET, FILM COATED in 1 BOTTLE
- ndc1125000080721 BOTTLE in 1 CARTON (25000-080-72) / 18 TABLET, FILM COATED in 1 BOTTLE
- ndc112500008074288 TABLET, FILM COATED in 1 BOTTLE (25000-080-74)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A216994
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": {
"44520aa1-b63f-4239-e063-6394a90a5e14": {
"match": "brand_token",
"title": "ACETAMINOPHEN LIQUID / ACETAMINOPHEN DIPHENHYDRAMINE HCL LIQUID (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [KROGER]",
"spl_version": "2",
"published_date": "2026-06-02"
}
},
"productid": "25000-080_38a01bed-7a8b-4aed-97c1-cc1545f76f79",
"productndc": "25000-080",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "216994",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "250MG;125MG",
"product_no": "001",
"approval_date": "Jul 10, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ACETAMINOPHEN; IBUPROFEN",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "Acetaminophen 250 mg and Ibuprofen 125 mg",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA216994",
"marketing_category": "ANDA",
"nonproprietary_name": "Acetaminophen 250 mg and Ibuprofen 125 mg Tablets",
"start_marketing_date": "20230711",
"active_numerator_strength": "250; 125"
}Related drugs
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