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United States · US · US:65841-759_691b64ae-e6ff-4a10-9973-886901529db0
Omeprazole
In shortageOrange BookUNIISPLATC A02BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeA02BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116584175901100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-759-01)
- ndc116584175905500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-759-05)
- ndc11658417590630 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-759-06)
- ndc1165841759101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-759-10)
- ndc11658417591690 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-759-16)
Annotations
UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
A091352
ABABAB
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": {
"b3ec4a44-5643-4438-b41b-e04946436719": {
"match": "brand_token",
"title": "OMEPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY]",
"spl_version": "3",
"published_date": "2026-05-29"
}
},
"productid": "65841-759_691b64ae-e6ff-4a10-9973-886901529db0",
"productndc": "65841-759",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "091352",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Nov 19, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Nov 19, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "003",
"approval_date": "Nov 19, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OMEPRAZOLE",
"shortage_reason": "Omeprazole Delayed Release Capsule",
"shortage_status": "current",
"proprietary_name": "Omeprazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091352",
"marketing_category": "ANDA",
"nonproprietary_name": "Omeprazole",
"start_marketing_date": "20121123",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code A02BC01.
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