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United States · US · US:70000-0381_867caf67-b128-4c09-9e35-352f8c04bcbe
Leader Omeprazole
In shortageOrange BookUNIISPLATC A02BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCardinal Health 110, LLC. dba Leader
CountryUS (United States)
ATC codeA02BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11700000381114 BLISTER PACK in 1 CARTON (70000-0381-1) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
- ndc1170000038123 CARTON in 1 CARTON (70000-0381-2) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
N209400
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": {
"12971fb2-2314-4443-bf70-b7eb5859b148": {
"match": "brand_token",
"title": "LEADER MUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]",
"spl_version": "3",
"published_date": "2026-06-01"
}
},
"productid": "70000-0381_867caf67-b128-4c09-9e35-352f8c04bcbe",
"productndc": "70000-0381",
"dosage_form": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE",
"orange_book": {
"appl_no": "209400",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "20MG",
"product_no": "001",
"approval_date": "Jul 5, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "OMEPRAZOLE",
"shortage_reason": "Omeprazole Delayed Release Capsule",
"shortage_status": "current",
"proprietary_name": "Leader Omeprazole",
"active_ingred_unit": "mg/1",
"application_number": "NDA209400",
"marketing_category": "NDA",
"nonproprietary_name": "omeprazole",
"start_marketing_date": "20180820",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BC01.
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