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United States · US · US:63548-4080_8289695b-99ab-44e6-a237-da93ec951d1e
Omeprazole
In shortageOrange BookUNIISPLATC A02BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPLD Acquisitions LLC DBA Av�ma Pharma Solutions
CountryUS (United States)
ATC codeA02BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11635484080242 BLISTER PACK in 1 CARTON (63548-4080-2) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
- ndc11635484080414 BLISTER PACK in 1 CARTON (63548-4080-4) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
- ndc11635484080828 BLISTER PACK in 1 CARTON (63548-4080-8) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
426QFE7XLK
OMEPRAZOLE MAGNESIUM
RxCUI 236486
Orange Book
A206582
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": "63548-4080_8289695b-99ab-44e6-a237-da93ec951d1e",
"productndc": "63548-4080",
"dosage_form": "TABLET, DELAYED RELEASE",
"orange_book": {
"appl_no": "206582",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Jun 1, 2020"
}
],
"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": "ANDA206582",
"marketing_category": "ANDA",
"nonproprietary_name": "Omeprazole",
"start_marketing_date": "20241031",
"active_numerator_strength": "20.6"
}Related drugs
Other records sharing ATC code A02BC01.
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