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United States · US · US:70000-0003_8d59690a-348c-4025-b3ef-b1a8500c7de4
leader ibuprofen
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCardinal Health 110, LLC. dba Leader
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1170000000311 BOTTLE in 1 CARTON (70000-0003-1) / 50 TABLET, FILM COATED in 1 BOTTLE
- ndc1170000000321 BOTTLE in 1 CARTON (70000-0003-2) / 100 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A077349
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": {
"12971fb2-2314-4443-bf70-b7eb5859b148": {
"match": "brand_token",
"title": "LEADER MUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]",
"spl_version": "3",
"published_date": "2026-06-01"
}
},
"productid": "70000-0003_8d59690a-348c-4025-b3ef-b1a8500c7de4",
"productndc": "70000-0003",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "077349",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "200MG",
"product_no": "001",
"approval_date": "Jun 21, 2005"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "leader ibuprofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077349",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20191218",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code G02CC01.
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