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United States · US · US:82804-078_7b92ac4f-50c9-4061-b4a7-535a58cea8f6
esomeprazole magnesium
Orange BookSPLATC A02BC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeA02BC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11828040783030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82804-078-30)
- ndc11828040786060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82804-078-60)
- ndc11828040789090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82804-078-90)
Annotations
Orange Book
A213486
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": "82804-078_7b92ac4f-50c9-4061-b4a7-535a58cea8f6",
"productndc": "82804-078",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "213486",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Mar 19, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "002",
"approval_date": "Mar 19, 2021"
}
],
"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": "ANDA213486",
"marketing_category": "ANDA",
"nonproprietary_name": "esomeprazole magnesium",
"start_marketing_date": "20210319",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code A02BC05.
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