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United States · US · US:25000-091_dcf79426-6aec-432a-aabe-dcb98c0f2cec
Omeprazole 20 mg
In shortageOrange BookUNIISPLATC A02BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMARKSANS PHARMA LIMITED
CountryUS (United States)
ATC codeA02BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1125000091761 BOTTLE in 1 CARTON (25000-091-76) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
- ndc1125000091772 BLISTER PACK in 1 CARTON (25000-091-77) / 7 TABLET, DELAYED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
426QFE7XLK
OMEPRAZOLE MAGNESIUM
RxCUI 236486
Orange Book
A218829
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": "25000-091_dcf79426-6aec-432a-aabe-dcb98c0f2cec",
"productndc": "25000-091",
"dosage_form": "TABLET, DELAYED RELEASE",
"orange_book": {
"appl_no": "218829",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Aug 7, 2025"
}
],
"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 20 mg",
"active_ingred_unit": "mg/1",
"application_number": "ANDA218829",
"marketing_category": "ANDA",
"nonproprietary_name": "Omeprazole 20 mg",
"start_marketing_date": "20250812",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BC01.
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