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United States · US · US:36800-194_4f159fc7-8379-465d-9a92-d3c8bffefdc6
TopCare Acid Reducer
Orange BookUNIISPLATC A02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeA02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11368001940225 BLISTER PACK in 1 CARTON (36800-194-02) / 1 TABLET, FILM COATED in 1 BLISTER PACK
- ndc1136800194711 BOTTLE in 1 CARTON (36800-194-71) / 50 TABLET, FILM COATED in 1 BOTTLE
- ndc1136800194781 BOTTLE in 1 CARTON (36800-194-78) / 100 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A077351
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5QZO15J2Z8",
"rxcui": "4278",
"inchikey": "XUFQPHANEAPEMJ-UHFFFAOYSA-N",
"display_name": "FAMOTIDINE",
"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": "36800-194_4f159fc7-8379-465d-9a92-d3c8bffefdc6",
"productndc": "36800-194",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "077351",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "20MG",
"product_no": "001",
"approval_date": "Sep 25, 2006"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "FAMOTIDINE",
"proprietary_name": "TopCare Acid Reducer",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077351",
"marketing_category": "ANDA",
"nonproprietary_name": "Famotidine",
"start_marketing_date": "20060928",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BA03.
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