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United States · US · US:58602-879_e1b49257-d226-457f-8f2d-9a757a65bbcb
Ibuprofen
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurohealth LLC
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115860287938300 CAPSULE in 1 BOTTLE (58602-879-38)
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A207753
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": "58602-879_e1b49257-d226-457f-8f2d-9a757a65bbcb",
"productndc": "58602-879",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "207753",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 200MG FREE ACID AND POTASSIUM SALT",
"product_no": "001",
"approval_date": "Jun 29, 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": "ANDA207753",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20220906",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code G02CC01.
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