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United States · US · US:57344-309_37ca0fdc-eaeb-4a5c-e063-6394a90a3a78
IBUPROFEN
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAAA Pharmaceutical, Inc.
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1157344309031 BOTTLE, PLASTIC in 1 CARTON (57344-309-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC
- ndc115734430915250 TABLET, COATED in 1 BOTTLE, PLASTIC (57344-309-15)
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A079174
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": "57344-309_37ca0fdc-eaeb-4a5c-e063-6394a90a3a78",
"productndc": "57344-309",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "079174",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "200MG",
"product_no": "001",
"approval_date": "Dec 10, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "IBUPROFEN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA079174",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20241205",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code G02CC01.
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