🇺🇸
United States · US · US:72657-157_b3d8d869-735e-4720-8b2b-a3eacc92041f
Acetaminophen, Ibuprofen
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGLENMARK THERAPEUTICS INC., USA
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc1172657157051 BOTTLE in 1 CARTON (72657-157-05) / 500 TABLET, FILM COATED in 1 BOTTLE
- ndc1172657157181 BOTTLE in 1 CARTON (72657-157-18) / 18 TABLET, FILM COATED in 1 BOTTLE
- ndc1172657157201 BOTTLE in 1 CARTON (72657-157-20) / 250 TABLET, FILM COATED in 1 BOTTLE
- ndc1172657157361 BOTTLE in 1 CARTON (72657-157-36) / 36 TABLET, FILM COATED in 1 BOTTLE
- ndc1172657157721 BOTTLE in 1 CARTON (72657-157-72) / 72 TABLET, FILM COATED in 1 BOTTLE
- ndc1172657157741 BOTTLE in 1 CARTON (72657-157-74) / 144 TABLET, FILM COATED in 1 BOTTLE
- ndc1172657157761 BOTTLE in 1 CARTON (72657-157-76) / 216 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A218311
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": {
"353ef34f-760d-ae92-e063-6294a90a5b4a": {
"match": "brand_token",
"title": "ACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESIN CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PVT LTD]",
"spl_version": "5",
"published_date": "2026-04-28"
}
},
"productid": "72657-157_b3d8d869-735e-4720-8b2b-a3eacc92041f",
"productndc": "72657-157",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "218311",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "250MG;125MG",
"product_no": "001",
"approval_date": "Apr 26, 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, Ibuprofen",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA218311",
"marketing_category": "ANDA",
"nonproprietary_name": "Acetaminophen, Ibuprofen",
"start_marketing_date": "20240507",
"active_numerator_strength": "250; 125"
}Related drugs
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