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United States · US · US:64980-632_8e9751a1-6130-44a5-bbf5-45c75479b8d2
Esomeprazole magnesium
Orange BookSPLATC A02BC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeA02BC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11649806320330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64980-632-03)
- ndc11649806320990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64980-632-09)
- ndc1164980632101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64980-632-10)
Annotations
Orange Book
A212949
ABAB
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": "64980-632_8e9751a1-6130-44a5-bbf5-45c75479b8d2",
"productndc": "64980-632",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "212949",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Oct 2, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "002",
"approval_date": "Oct 2, 2020"
}
],
"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": "ANDA212949",
"marketing_category": "ANDA",
"nonproprietary_name": "Esomeprazole magnesium",
"start_marketing_date": "20240726",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BC05.
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