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United States · US · US:36800-295_d6083bce-520b-4c14-bd0f-698e33b4b4f6
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 · 1
- ndc11368002957414 BLISTER PACK in 1 CARTON (36800-295-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
0K5C5T2QPG
LANSOPRAZOLE
RxCUI 17128
Orange Book
N208025
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": "36800-295_d6083bce-520b-4c14-bd0f-698e33b4b4f6",
"productndc": "36800-295",
"dosage_form": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE",
"orange_book": {
"appl_no": "208025",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "15MG",
"product_no": "001",
"approval_date": "Jun 7, 2016"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LANSOPRAZOLE",
"proprietary_name": "topcare Lansoprazole",
"active_ingred_unit": "mg/1",
"application_number": "NDA208025",
"marketing_category": "NDA",
"nonproprietary_name": "lansoprazole",
"start_marketing_date": "20200618",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code A02BC03.
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