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United States · US · US:68462-390_5eef4592-c7ef-454c-88a9-62671fff9088
Esomeprazole Magnesium
Orange BookSPLATC A02BC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeA02BC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1168462390101000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-390-10)
- ndc11684623903030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-390-30)
- ndc11684623909090 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-390-90)
Annotations
Orange Book
A209495
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"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": "68462-390_5eef4592-c7ef-454c-88a9-62671fff9088",
"productndc": "68462-390",
"dosage_form": "CAPSULE, DELAYED RELEASE PELLETS",
"orange_book": {
"appl_no": "209495",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "May 10, 2019"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 40MG BASE",
"product_no": "002",
"approval_date": "May 10, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESOMEPRAZOLE MAGNESIUM",
"proprietary_name": "Esomeprazole Magnesium",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209495",
"marketing_category": "ANDA",
"nonproprietary_name": "Esomeprazole Magnesium",
"start_marketing_date": "20211101",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BC05.
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