🇺🇸
United States · US · US:43598-052_49a54544-f18b-6461-9ed0-2740e8df4b6c
Acetaminophen 250 mg and Ibuprofen 125 mg
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Labortories Inc
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc114359805205500 TABLET, FILM COATED in 1 BOTTLE (43598-052-05)
- ndc114359805214144 TABLET, FILM COATED in 1 BOTTLE (43598-052-14)
- ndc1143598052181 BOTTLE in 1 CARTON (43598-052-18) / 18 TABLET, FILM COATED in 1 BOTTLE
- ndc1143598052251 BOTTLE in 1 CARTON (43598-052-25) / 250 TABLET, FILM COATED in 1 BOTTLE
- ndc114359805295250 TABLET, FILM COATED in 1 BOTTLE (43598-052-95)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A218247
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": "43598-052_49a54544-f18b-6461-9ed0-2740e8df4b6c",
"productndc": "43598-052",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "218247",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "250MG;125MG",
"product_no": "001",
"approval_date": "Aug 23, 2024"
}
],
"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": "ANDA218247",
"marketing_category": "ANDA",
"nonproprietary_name": "Acetaminophen and Ibuprofen",
"start_marketing_date": "20250219",
"active_numerator_strength": "250; 125"
}Related drugs
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