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United States · US · US:69396-172_3729a3d5-0ccd-378f-e063-6294a90aa65c
Ibuprofen
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTrifecta Pharmaceuticals USA LLC
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169396172011000 TABLET in 1 BOTTLE (69396-172-01)
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A207095
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": "69396-172_3729a3d5-0ccd-378f-e063-6294a90aa65c",
"productndc": "69396-172",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "207095",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "200MG",
"product_no": "001",
"approval_date": "May 5, 2017"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "200MG",
"product_no": "002",
"approval_date": "Aug 21, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Ibuprofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA207095",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20230808",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code G02CC01.
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