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United States · US · US:16571-880_cd6b21e6-4d3f-40b5-89ee-52a1c83d8700
ESOMEPRAZOLE MAGNESIUM
Orange BookSPLATC A02BC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeA02BC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1116571880411 BOTTLE in 1 CARTON (16571-880-41) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
- ndc1116571880423 BOTTLE in 1 CARTON (16571-880-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Annotations
Orange Book
A216349
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": "16571-880_cd6b21e6-4d3f-40b5-89ee-52a1c83d8700",
"productndc": "16571-880",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "216349",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Jun 24, 2022"
}
],
"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": "ANDA216349",
"marketing_category": "ANDA",
"nonproprietary_name": "ESOMEPRAZOLE MAGNESIUM",
"start_marketing_date": "20221201",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BC05.
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