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United States · US · US:71205-522_89d2987c-469d-416c-b81b-70a3fff64427
Ibuprofen
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc11712055222020 TABLET, FILM COATED in 1 BOTTLE (71205-522-20)
- ndc11712055222828 TABLET, FILM COATED in 1 BOTTLE (71205-522-28)
- ndc11712055223030 TABLET, FILM COATED in 1 BOTTLE (71205-522-30)
- ndc11712055224242 TABLET, FILM COATED in 1 BOTTLE (71205-522-42)
- ndc11712055226060 TABLET, FILM COATED in 1 BOTTLE (71205-522-60)
- ndc11712055229090 TABLET, FILM COATED in 1 BOTTLE (71205-522-90)
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A078329
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": "71205-522_89d2987c-469d-416c-b81b-70a3fff64427",
"productndc": "71205-522",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078329",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "001",
"approval_date": "Feb 5, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "002",
"approval_date": "Feb 5, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "003",
"approval_date": "Feb 5, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Ibuprofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078329",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20180824",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code G02CC01.
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