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United States · US · US:69168-472_8544b126-0544-4f7c-a5f6-3cc1b136505d
Esomeprazole Magnesium
Orange BookSPLATC A02BC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAllegiant Health
CountryUS (United States)
ATC codeA02BC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc1169168472141 BOTTLE in 1 CARTON (69168-472-14) / 14 CAPSULE in 1 BOTTLE
- ndc11691684721514 CAPSULE in 1 BOTTLE (69168-472-15)
- ndc1169168472423 BOTTLE in 1 CARTON (69168-472-42) / 14 CAPSULE in 1 BOTTLE
- ndc1169168472611 BOTTLE in 1 CARTON (69168-472-61) / 14 CAPSULE in 1 BOTTLE
- ndc1169168472623 BOTTLE in 1 CARTON (69168-472-62) / 14 CAPSULE in 1 BOTTLE
Annotations
Orange Book
A212507
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": "69168-472_8544b126-0544-4f7c-a5f6-3cc1b136505d",
"productndc": "69168-472",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "212507",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Jun 2, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ESOMEPRAZOLE MAGNESIUM",
"proprietary_name": "Esomeprazole Magnesium",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212507",
"marketing_category": "ANDA",
"nonproprietary_name": "esomeprazole magnesium capsule, delayed release",
"start_marketing_date": "20250515",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BC05.
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