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United States · US · US:70954-798_63c3bd6c-a586-4ec0-8f45-ed936936dfeb
Omeprazole and Sodium Bicarbonate
Orange BookUNIISPLATC A02BC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA02BC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11709547982030 PACKET in 1 CARTON (70954-798-20) / 1 POWDER, FOR SUSPENSION in 1 PACKET (70954-798-10)
Annotations
UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
A219161
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": "70954-798_63c3bd6c-a586-4ec0-8f45-ed936936dfeb",
"productndc": "70954-798",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "219161",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG/PACKET;1.68GM/PACKET",
"product_no": "001",
"approval_date": "Dec 10, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG/PACKET;1.68GM/PACKET",
"product_no": "002",
"approval_date": "Dec 10, 2025"
}
],
"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": "ANDA219161",
"marketing_category": "ANDA",
"nonproprietary_name": "Omeprazole and Sodium Bicarbonate",
"start_marketing_date": "20260115",
"active_numerator_strength": "40; 1680"
}Related drugs
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