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United States · US · US:33342-306_d68c9247-91c7-4e0f-adc4-2cfa7446580f
esomeprazole
Orange BookUNIISPLATC A02BC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeA02BC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11333423060730 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-306-07)
- ndc11333423061090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-306-10)
Annotations
UNII (FDA Substance ID)
N3PA6559FT
ESOMEPRAZOLE
RxCUI 283742
Orange Book
A208511
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "N3PA6559FT",
"rxcui": "283742",
"inchikey": "SUBDBMMJDZJVOS-DEOSSOPVSA-N",
"display_name": "ESOMEPRAZOLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"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": "33342-306_d68c9247-91c7-4e0f-adc4-2cfa7446580f",
"productndc": "33342-306",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "208511",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Oct 23, 2024"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 40MG BASE",
"product_no": "002",
"approval_date": "Oct 23, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESOMEPRAZOLE",
"proprietary_name": "esomeprazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA208511",
"marketing_category": "ANDA",
"nonproprietary_name": "esomeprazole",
"start_marketing_date": "20241023",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BC05.
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