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United States · US · US:50228-364_25403f99-6570-5b4b-e063-6294a90a9963
Omeprazole and Sodium Bicarbonate
Orange BookUNIISPLATC A02BC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerScieGen Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA02BC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc115022836405500 CAPSULE in 1 BOTTLE (50228-364-05)
- ndc11502283643030 CAPSULE in 1 BOTTLE (50228-364-30)
Annotations
UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
A207476
ABAB
DailyMed SPL labels
1 version tracked
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": {
"b3ec4a44-5643-4438-b41b-e04946436719": {
"match": "brand_token",
"title": "OMEPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY]",
"spl_version": "3",
"published_date": "2026-05-29"
}
},
"productid": "50228-364_25403f99-6570-5b4b-e063-6294a90a9963",
"productndc": "50228-364",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "207476",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG;1.1GM",
"product_no": "001",
"approval_date": "Dec 6, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG;1.1GM",
"product_no": "002",
"approval_date": "Dec 6, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OMEPRAZOLE; SODIUM BICARBONATE",
"proprietary_name": "Omeprazole and Sodium Bicarbonate",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA207476",
"marketing_category": "ANDA",
"nonproprietary_name": "Omeprazole and Sodium Bicarbonate",
"start_marketing_date": "20161206",
"active_numerator_strength": "40; 1100"
}Related drugs
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