🇺🇸
United States · US · US:71610-876_2dcd4083-bade-a7bd-e063-6294a90a7169
Omeprazole
In shortageOrange BookUNIISPLATC A02BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeA02BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11716108765360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-876-53)
- ndc11716108766090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-876-60)
- ndc117161087670120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-876-70)
- ndc117161087680180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-876-80)
Annotations
UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
A078490
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": "71610-876_2dcd4083-bade-a7bd-e063-6294a90a7169",
"productndc": "71610-876",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "078490",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "001",
"approval_date": "Apr 17, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Mar 16, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "003",
"approval_date": "Mar 16, 2009"
}
],
"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": "ANDA078490",
"marketing_category": "ANDA",
"nonproprietary_name": "Omeprazole",
"start_marketing_date": "20140301",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code A02BC01.
Access this data programmatically
Query Omeprazole and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.