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United States · US · US:70771-1392_983313a8-2120-4c76-8412-0c0c6a159465
Esomeprazole Magnesium
Orange BookUNIISPLATC A02BC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeA02BC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11707711392330 GRANULE, DELAYED RELEASE in 1 CARTON (70771-1392-3)
Annotations
UNII (FDA Substance ID)
36H71644EQ
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
RxCUI 1601995
Orange Book
A206055
ABAB
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": "70771-1392_983313a8-2120-4c76-8412-0c0c6a159465",
"productndc": "70771-1392",
"dosage_form": "GRANULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "206055",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE/PACKET",
"product_no": "001",
"approval_date": "Jun 7, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE/PACKET",
"product_no": "002",
"approval_date": "Jun 7, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESOMEPRAZOLE MAGNESIUM DIHYDRATE",
"proprietary_name": "Esomeprazole Magnesium",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206055",
"marketing_category": "ANDA",
"nonproprietary_name": "Esomeprazole Magnesium",
"start_marketing_date": "20230630",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code A02BC05.
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