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United States · US · US:45865-163_1278c4e8-89c4-94b5-e063-6294a90a7d73
Esomeprazole Magnesium
Orange BookSPLATC A02BC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMedsource Pharmaceuticals
CountryUS (United States)
ATC codeA02BC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11458651633030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45865-163-30)
- ndc11458651636060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45865-163-60)
Annotations
Orange Book
A078279
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": "45865-163_1278c4e8-89c4-94b5-e063-6294a90a7d73",
"productndc": "45865-163",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "078279",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Sep 25, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "002",
"approval_date": "Sep 25, 2015"
}
],
"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": "ANDA078279",
"marketing_category": "ANDA",
"nonproprietary_name": "Esomeprazole Magnesium",
"start_marketing_date": "20151210",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BC05.
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