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United States · US · US:76420-227_23b36bd4-0dbd-366a-e063-6294a90a1565
Esomeprazole magnesium
Orange BookSPLATC A02BC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeA02BC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11764202273030 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-227-30)
- ndc11764202276060 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-227-60)
- ndc11764202279090 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-227-90)
Annotations
Orange Book
A210559
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": "76420-227_23b36bd4-0dbd-366a-e063-6294a90a1565",
"productndc": "76420-227",
"dosage_form": "CAPSULE, COATED PELLETS",
"orange_book": {
"appl_no": "210559",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Feb 26, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "002",
"approval_date": "Feb 26, 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": "ANDA210559",
"marketing_category": "ANDA",
"nonproprietary_name": "Esomeprazole magnesium delayed release capsules",
"start_marketing_date": "20210227",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code A02BC05.
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