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United States · US · US:36800-121_f384bca8-e266-489a-8d87-3df17e7d0a56
TopCare Omeprazole delayed release
In shortageOrange BookUNIISPLATC A02BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeA02BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1136800121011 BOTTLE in 1 CARTON (36800-121-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
- ndc1136800121033 BOTTLE in 1 CARTON (36800-121-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
N022032
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Omeprazole Delayed Release Capsule
Raw payload (JSON)
{
"unii": {
"unii": "KG60484QX9",
"rxcui": "7646",
"inchikey": "SUBDBMMJDZJVOS-UHFFFAOYSA-N",
"display_name": "OMEPRAZOLE",
"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": "36800-121_f384bca8-e266-489a-8d87-3df17e7d0a56",
"productndc": "36800-121",
"dosage_form": "TABLET, DELAYED RELEASE",
"orange_book": {
"appl_no": "022032",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "20MG",
"product_no": "001",
"approval_date": "Dec 4, 2007"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "OMEPRAZOLE",
"shortage_reason": "Omeprazole Delayed Release Capsule",
"shortage_status": "current",
"proprietary_name": "TopCare Omeprazole delayed release",
"active_ingred_unit": "mg/1",
"application_number": "NDA022032",
"marketing_category": "NDA",
"nonproprietary_name": "Omeprazole",
"start_marketing_date": "20160202",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BC01.
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