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United States · US · US:53746-143_e2b9bf54-0449-4f9b-86e8-e3b292387dd5
Ibuprofen
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc115374614301100 TABLET in 1 BOTTLE (53746-143-01)
- ndc1153746143101000 TABLET in 1 BOTTLE (53746-143-10)
- ndc11537461432424 TABLET in 1 BOTTLE (53746-143-24)
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A071333
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": "53746-143_e2b9bf54-0449-4f9b-86e8-e3b292387dd5",
"productndc": "53746-143",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "071333",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "200MG",
"product_no": "001",
"approval_date": "Feb 17, 1987"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Ibuprofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA071333",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20091216",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code G02CC01.
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