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United States · US · US:36800-627_61351d9f-87dd-4586-a46a-9ab7fabe41ce
topcare esomeprazole magnesium
Orange BookUNIISPLATC A02BC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeA02BC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1136800627011 BOTTLE in 1 CARTON (36800-627-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
- ndc1136800627033 BOTTLE in 1 CARTON (36800-627-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
36H71644EQ
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
RxCUI 1601995
Orange Book
A207193
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "36H71644EQ",
"rxcui": "1601995",
"inchikey": "DBOUSUONOXEWHU-VCKZSRROSA-N",
"display_name": "ESOMEPRAZOLE MAGNESIUM DIHYDRATE",
"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": "36800-627_61351d9f-87dd-4586-a46a-9ab7fabe41ce",
"productndc": "36800-627",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "207193",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Aug 18, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ESOMEPRAZOLE MAGNESIUM DIHYDRATE",
"proprietary_name": "topcare esomeprazole magnesium",
"active_ingred_unit": "mg/1",
"application_number": "ANDA207193",
"marketing_category": "ANDA",
"nonproprietary_name": "esomeprazole magnesium",
"start_marketing_date": "20200312",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BC05.
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