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United States · US · US:36800-392_f5217e63-e0c1-4899-8bf0-e480d65e282f
topcare lansoprazole
Orange BookUNIISPLATC A02BC03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeA02BC03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1136800392011 BOTTLE in 1 CARTON (36800-392-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
- ndc1136800392033 BOTTLE in 1 CARTON (36800-392-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
0K5C5T2QPG
LANSOPRAZOLE
RxCUI 17128
Orange Book
A202319
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0K5C5T2QPG",
"rxcui": "17128",
"inchikey": "MJIHNNLFOKEZEW-UHFFFAOYSA-N",
"display_name": "LANSOPRAZOLE",
"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": "36800-392_f5217e63-e0c1-4899-8bf0-e480d65e282f",
"productndc": "36800-392",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "202319",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "15MG",
"product_no": "001",
"approval_date": "May 18, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LANSOPRAZOLE",
"proprietary_name": "topcare lansoprazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202319",
"marketing_category": "ANDA",
"nonproprietary_name": "Lansoprazole",
"start_marketing_date": "20210729",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code A02BC03.
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