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United States · US · US:53185-381_9925c48b-f4aa-4393-b877-84307eb271e1
Ibuprofen 200mg
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAthlete's Needs, Inc.
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115318538101100 TABLET, COATED in 1 BOTTLE (53185-381-01)
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A202312
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": "53185-381_9925c48b-f4aa-4393-b877-84307eb271e1",
"productndc": "53185-381",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "202312",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "200MG",
"product_no": "001",
"approval_date": "Oct 7, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Ibuprofen 200mg",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202312",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen 200mg",
"start_marketing_date": "20161007",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code G02CC01.
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