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United States · US · US:58602-809_2d45adc7-14a7-4377-b51d-da80f800b027
Esomeprazole Magnesium
Orange BookUNIISPLATC A02BC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurohealth LLC
CountryUS (United States)
ATC codeA02BC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1158602809051 BOTTLE in 1 CARTON (58602-809-05) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
- ndc1158602809612 BOTTLE in 1 CARTON (58602-809-61) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
- ndc1158602809623 BOTTLE in 1 CARTON (58602-809-62) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
36H71644EQ
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
RxCUI 1601995
Orange Book
A209339
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "36H71644EQ",
"rxcui": "1601995",
"inchikey": "DBOUSUONOXEWHU-VCKZSRROSA-N",
"display_name": "ESOMEPRAZOLE MAGNESIUM DIHYDRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"6a21f085-b60b-49b7-8098-99ccdc43dde3": {
"match": "brand_token",
"title": "ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE 20 MG (OTC) CAPSULE, DELAYED RELEASE ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE 20 MG MINI CAPSULE, DELAYED RELEASE [MARKSANS PHARMA LIMITED]",
"spl_version": "3",
"published_date": "2026-06-02"
}
},
"productid": "58602-809_2d45adc7-14a7-4377-b51d-da80f800b027",
"productndc": "58602-809",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "209339",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Oct 16, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ESOMEPRAZOLE MAGNESIUM DIHYDRATE",
"proprietary_name": "Esomeprazole Magnesium",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209339",
"marketing_category": "ANDA",
"nonproprietary_name": "Esomeprazole Magnesium",
"start_marketing_date": "20171016",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BC05.
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