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United States · US · US:67877-321_8050d9d9-0b0b-4136-be37-a824114f7ea0
Ibuprofen
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116787732101100 TABLET, FILM COATED in 1 BOTTLE (67877-321-01)
- ndc116787732105500 TABLET, FILM COATED in 1 BOTTLE (67877-321-05)
- ndc11678773212711400 TABLET, FILM COATED in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (67877-321-27)
- ndc11678773213030 TABLET, FILM COATED in 1 BOTTLE (67877-321-30)
- ndc11678773215050 TABLET, FILM COATED in 1 BOTTLE (67877-321-50)
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A091625
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "WK2XYI10QM",
"rxcui": "5640",
"inchikey": "HEFNNWSXXWATRW-UHFFFAOYSA-N",
"display_name": "IBUPROFEN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"aeee629b-255c-40d8-8e95-779aec00f723": {
"match": "brand_token",
"title": "IBUPROFEN TABLET [NORTHSTAR RX LLC]",
"spl_version": "1",
"published_date": "2026-06-02"
}
},
"productid": "67877-321_8050d9d9-0b0b-4136-be37-a824114f7ea0",
"productndc": "67877-321",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "091625",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "001",
"approval_date": "Sep 15, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "002",
"approval_date": "Sep 15, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "003",
"approval_date": "Sep 15, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Ibuprofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091625",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20151221",
"active_numerator_strength": "800"
}Related drugs
Other records sharing ATC code G02CC01.
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