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United States · US · US:57483-740_ce5c9fdc-0c50-4315-8f11-e00c9810abd0
omeprazole
In shortageOrange BookUNIISPLATC A02BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerINNOVUS PHARMACEUTICALS, INC.
CountryUS (United States)
ATC codeA02BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1157483740423 BOTTLE in 1 CARTON (57483-740-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57483-740-01)
Annotations
UNII (FDA Substance ID)
426QFE7XLK
OMEPRAZOLE MAGNESIUM
RxCUI 236486
Orange Book
A210593
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Omeprazole Delayed Release Capsule
Raw payload (JSON)
{
"unii": {
"unii": "426QFE7XLK",
"rxcui": "236486",
"inchikey": "KWORUUGOSLYAGD-UHFFFAOYSA-N",
"display_name": "OMEPRAZOLE MAGNESIUM",
"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": "57483-740_ce5c9fdc-0c50-4315-8f11-e00c9810abd0",
"productndc": "57483-740",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "210593",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Jul 20, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "OMEPRAZOLE MAGNESIUM",
"shortage_reason": "Omeprazole Delayed Release Capsule",
"shortage_status": "current",
"proprietary_name": "omeprazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210593",
"marketing_category": "ANDA",
"nonproprietary_name": "omeprazole",
"start_marketing_date": "20200806",
"active_numerator_strength": "20.6"
}Related drugs
Other records sharing ATC code A02BC01.
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