🇺🇸
United States · US · US:64380-182_2ac68a93-2f3b-46aa-a874-c109ad1bfefe
Omeprazole/Sodium Bicarbonate
Orange BookUNIISPLATC A02BC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerStrides Pharma Science Limited
CountryUS (United States)
ATC codeA02BC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11643801820230 POUCH in 1 CARTON (64380-182-02) / 20 mg in 1 POUCH (64380-182-01)
Annotations
UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
A079182
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": {
"cf6d293e-d70d-443e-8292-d693e93aab55": {
"match": "brand_token",
"title": "OMEPRAZOLE/SODIUM BICARBONATE (OMEPRAZOLE) POWDER, FOR SUSPENSION [STRIDES PHARMA SCIENCE LIMITED]",
"spl_version": "5",
"published_date": "2023-12-13"
}
},
"productid": "64380-182_2ac68a93-2f3b-46aa-a874-c109ad1bfefe",
"productndc": "64380-182",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "079182",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG/PACKET;1.68GM/PACKET",
"product_no": "001",
"approval_date": "Apr 19, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG/PACKET;1.68GM/PACKET",
"product_no": "002",
"approval_date": "Apr 19, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OMEPRAZOLE; SODIUM BICARBONATE",
"proprietary_name": "Omeprazole/Sodium Bicarbonate",
"active_ingred_unit": "mg/1700mg; mg/1700mg",
"application_number": "ANDA079182",
"marketing_category": "ANDA",
"nonproprietary_name": "omeprazole",
"start_marketing_date": "20221001",
"active_numerator_strength": "20; 1680"
}Related drugs
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