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United States · US · US:36800-193_427b861c-4464-a4b3-e063-6394a90aefb5
Ibuprofen
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTOP CARE (Topco Associates LLC)
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1136800193111 BOTTLE in 1 CARTON (36800-193-11) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
- ndc1136800193151 BOTTLE in 1 CARTON (36800-193-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
- ndc11368001937880 CAPSULE, LIQUID FILLED in 1 BOTTLE (36800-193-78)
- ndc113680019383300 CAPSULE, LIQUID FILLED in 1 BOTTLE (36800-193-83)
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A078682
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": "36800-193_427b861c-4464-a4b3-e063-6394a90aefb5",
"productndc": "36800-193",
"dosage_form": "CAPSULE, LIQUID FILLED",
"orange_book": {
"appl_no": "078682",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 200MG FREE ACID AND POTASSIUM SALT",
"product_no": "001",
"approval_date": "Mar 24, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Ibuprofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078682",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20210702",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code G02CC01.
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