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United States · US · US:71921-181_1f260910-03d9-fa2f-e063-6294a90ac0b9
Ibuprofen
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFlorida Pharmaceutical Products, LLC
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc117192118101100 TABLET, FILM COATED in 1 BOTTLE (71921-181-01)
- ndc117192118150500 TABLET, FILM COATED in 1 BOTTLE (71921-181-50)
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A071268
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": "71921-181_1f260910-03d9-fa2f-e063-6294a90ac0b9",
"productndc": "71921-181",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "071268",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "001",
"approval_date": "Oct 15, 1986"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "002",
"approval_date": "Oct 15, 1986"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "003",
"approval_date": "Jul 1, 1988"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Ibuprofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA071268",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20211021",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code G02CC01.
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