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United States · US · US:51672-1385_46f3c164-da78-0045-e063-6294a90a6885
Ibuprofen
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1151672138581 BOTTLE in 1 CARTON (51672-1385-8) / 118 mL in 1 BOTTLE
- ndc115167213859473 mL in 1 BOTTLE (51672-1385-9)
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A209204
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": "51672-1385_46f3c164-da78-0045-e063-6294a90a6885",
"productndc": "51672-1385",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "209204",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG/5ML",
"product_no": "001",
"approval_date": "Jun 23, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Ibuprofen",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA209204",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20170623",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code G02CC01.
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