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United States · US · US:70000-0727_70bfe4f8-4dba-4b46-abbd-7ff48928c9d5
leader esomeprazole magnesium
Orange BookUNIISPLATC A02BC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCardinal Health 110, LLC. dba Leader
CountryUS (United States)
ATC codeA02BC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1170000072713 BOTTLE in 1 CARTON (70000-0727-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
- ndc1170000072721 BOTTLE in 1 CARTON (70000-0727-2) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
N3PA6559FT
ESOMEPRAZOLE
RxCUI 283742
Orange Book
A207193
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "N3PA6559FT",
"rxcui": "283742",
"inchikey": "SUBDBMMJDZJVOS-DEOSSOPVSA-N",
"display_name": "ESOMEPRAZOLE",
"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": "70000-0727_70bfe4f8-4dba-4b46-abbd-7ff48928c9d5",
"productndc": "70000-0727",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "207193",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Aug 18, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ESOMEPRAZOLE",
"proprietary_name": "leader esomeprazole magnesium",
"active_ingred_unit": "mg/1",
"application_number": "ANDA207193",
"marketing_category": "ANDA",
"nonproprietary_name": "Esomeprazole",
"start_marketing_date": "20250402",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BC05.
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