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United States · US · US:36800-647_02993180-71f3-4807-bc0d-45d10238c7a8
Topcare Ibuprofen
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1136800647621 BOTTLE in 1 CARTON (36800-647-62) / 24 TABLET, FILM COATED in 1 BOTTLE
- ndc1136800647711 BOTTLE in 1 CARTON (36800-647-71) / 50 TABLET, FILM COATED in 1 BOTTLE
- ndc1136800647781 BOTTLE in 1 CARTON (36800-647-78) / 100 TABLET, FILM COATED in 1 BOTTLE
- ndc113680064790500 TABLET, FILM COATED in 1 BOTTLE (36800-647-90)
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A072096
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": {
"a88e5b8e-e6dd-4a1c-9628-5861d3205bdb": {
"match": "brand_token",
"title": "TOPCARE DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]",
"spl_version": "10",
"published_date": "2026-06-01"
}
},
"productid": "36800-647_02993180-71f3-4807-bc0d-45d10238c7a8",
"productndc": "36800-647",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "072096",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "200MG",
"product_no": "001",
"approval_date": "Dec 8, 1987"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Topcare Ibuprofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA072096",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "19881115",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code G02CC01.
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