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United States · US · US:69434-012_e9332607-e8e1-4b84-884a-7ae2b4313fb7
Esomeprazole magnesium
Orange BookSPLATC A02BC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZhejiang Yongtai Pharmaceutical Co., Ltd
CountryUS (United States)
ATC codeA02BC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11694340120130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69434-012-01)
- ndc11694340120290 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69434-012-02)
- ndc116943401203500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69434-012-03)
Annotations
Orange Book
A217022
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": "69434-012_e9332607-e8e1-4b84-884a-7ae2b4313fb7",
"productndc": "69434-012",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "217022",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Dec 27, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "002",
"approval_date": "Dec 27, 2023"
}
],
"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": "ANDA217022",
"marketing_category": "ANDA",
"nonproprietary_name": "Esomeprazole magnesium",
"start_marketing_date": "20250109",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BC05.
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