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United States · US · US:70000-0723_01e166d4-7ac5-421f-87d2-7b647631bf8d
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 · 3
- ndc1170000072311 BOTTLE in 1 CARTON (70000-0723-1) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
- ndc11700000723214 BLISTER PACK in 1 CARTON (70000-0723-2) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
- ndc1170000072333 BOTTLE in 1 CARTON (70000-0723-3) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
N022032
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": "70000-0723_01e166d4-7ac5-421f-87d2-7b647631bf8d",
"productndc": "70000-0723",
"dosage_form": "TABLET, DELAYED RELEASE",
"orange_book": {
"appl_no": "022032",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "20MG",
"product_no": "001",
"approval_date": "Dec 4, 2007"
}
],
"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": "NDA022032",
"marketing_category": "NDA",
"nonproprietary_name": "Omeprazole",
"start_marketing_date": "20250416",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BC01.
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