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United States · US · US:68682-104_342c0d17-867e-d8da-e063-6394a90a3151
Omeprazole and Sodium Bicarbonate
Orange BookUNIISPLATC A02BC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOceanside Pharmaceuticals
CountryUS (United States)
ATC codeA02BC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11686821043030 CAPSULE in 1 BOTTLE (68682-104-30)
Annotations
UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
N021849
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": "68682-104_342c0d17-867e-d8da-e063-6394a90a3151",
"productndc": "68682-104",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "021849",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Feb 27, 2006"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "002",
"approval_date": "Feb 27, 2006"
}
],
"appl_type": "N"
},
"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": "NDA021849",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "omeprazole, sodium bicarbonate",
"start_marketing_date": "20060227",
"active_numerator_strength": "40; 1100"
}Related drugs
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