🇺🇸
United States · US · US:46122-818_35313676-9f45-76fc-e063-6294a90a24a9
Acetaminophen and Ibuprofen
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAMERISOURCE BERGEN
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1146122818611 BOTTLE in 1 CARTON (46122-818-61) / 80 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A216999
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": "46122-818_35313676-9f45-76fc-e063-6294a90a24a9",
"productndc": "46122-818",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "216999",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "250MG;125MG",
"product_no": "001",
"approval_date": "Aug 1, 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 and Ibuprofen",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA216999",
"marketing_category": "ANDA",
"nonproprietary_name": "Acetaminophen and Ibuprofen",
"start_marketing_date": "20250515",
"active_numerator_strength": "250; 125"
}Related drugs
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