🇺🇸
United States · US · US:69848-588_2a306431-7813-346e-e063-6294a90aca46
Aacetaminophen and Ibuprofen
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGRANULES USA, INC.
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11698485887272 TABLET in 1 BOTTLE (69848-588-72)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A216592
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": {
"1dd90684-6505-8e07-e063-6394a90afdf4": {
"match": "brand_token",
"title": "AACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN AND IBUPROFEN) TABLET [GRANULES USA, INC.]",
"spl_version": "2",
"published_date": "2025-12-25"
}
},
"productid": "69848-588_2a306431-7813-346e-e063-6294a90aca46",
"productndc": "69848-588",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "216592",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "250MG;125MG",
"product_no": "001",
"approval_date": "Jul 13, 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": "Aacetaminophen and Ibuprofen",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA216592",
"marketing_category": "ANDA",
"nonproprietary_name": "Acetaminophen and Ibuprofen",
"start_marketing_date": "20241210",
"active_numerator_strength": "250; 125"
}Related drugs
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