🇺🇸
United States · US · US:64380-997_5f919f0a-7dad-405f-b383-dcde4091b5ec
Ibuprofen
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerStrides Pharma Science Limited
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1164380997031 BOTTLE in 1 CARTON (64380-997-03) / 118 mL in 1 BOTTLE
- ndc116438099704473 mL in 1 BOTTLE (64380-997-04)
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A215311
AB
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": "64380-997_5f919f0a-7dad-405f-b383-dcde4091b5ec",
"productndc": "64380-997",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "215311",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG/5ML",
"product_no": "001",
"approval_date": "May 27, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Ibuprofen",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA215311",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20230919",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code G02CC01.
Access this data programmatically
Query Ibuprofen and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.