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United States · US · US:80425-0070_2a98d9c1-b775-40b1-e063-6294a90a20e4
Omeprazole
In shortageOrange BookUNIISPLATC A02BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx of Tennessee, LLC
CountryUS (United States)
ATC codeA02BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11804250070130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0070-1)
- ndc11804250070260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0070-2)
- ndc118042500703120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0070-3)
- ndc11804250070490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0070-4)
Annotations
UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
A091672
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": "80425-0070_2a98d9c1-b775-40b1-e063-6294a90a20e4",
"productndc": "80425-0070",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "091672",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Oct 31, 2014"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Oct 31, 2014"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "003",
"approval_date": "Oct 31, 2014"
}
],
"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": "ANDA091672",
"marketing_category": "ANDA",
"nonproprietary_name": "Omeprazole",
"start_marketing_date": "20141031",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BC01.
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