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United States · US · US:68788-4104_319d990e-161b-4c16-b026-f55c413c7e8f
Omeprazole
In shortageOrange BookUNIISPLATC A02BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Phharmaceuticals Inc.
CountryUS (United States)
ATC codeA02BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc116878841041100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-4104-1)
- ndc11687884104220 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-4104-2)
- ndc11687884104330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-4104-3)
- ndc11687884104414 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-4104-4)
- ndc11687884104660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-4104-6)
- ndc116878841048120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-4104-8)
- ndc11687884104990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-4104-9)
Annotations
UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
A203270
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": "68788-4104_319d990e-161b-4c16-b026-f55c413c7e8f",
"productndc": "68788-4104",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "203270",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Aug 19, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Aug 19, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "003",
"approval_date": "Aug 19, 2015"
}
],
"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": "ANDA203270",
"marketing_category": "ANDA",
"nonproprietary_name": "Omeprazole",
"start_marketing_date": "20260421",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BC01.
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