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United States · US · US:67877-479_c6b5c112-5f5b-453a-836f-54bac8c7dca9
Esomeprazole magnesium
Orange BookSPLATC A02BC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeA02BC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116787747905500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-479-05)
- ndc1167877479101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-479-10)
- ndc11678774793030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-479-30)
- ndc11678774793810 BLISTER PACK in 1 CARTON (67877-479-38) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
- ndc11678774799090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-479-90)
Annotations
Orange Book
A208333
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": "67877-479_c6b5c112-5f5b-453a-836f-54bac8c7dca9",
"productndc": "67877-479",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "208333",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Oct 20, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "002",
"approval_date": "Oct 20, 2017"
}
],
"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": "ANDA208333",
"marketing_category": "ANDA",
"nonproprietary_name": "Esomeprazole magnesium",
"start_marketing_date": "20171020",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code A02BC05.
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