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United States · US · US:57664-501_f5e842da-4922-4f1d-b2e0-a4c0be71e2a6
Mirtazapine
Orange BookUNIISPLATC N06AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeN06AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1157664501181000 TABLET in 1 BOTTLE (57664-501-18)
- ndc11576645018330 TABLET in 1 BOTTLE (57664-501-83)
Annotations
UNII (FDA Substance ID)
A051Q2099Q
MIRTAZAPINE
RxCUI 15996
Orange Book
A076541
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "A051Q2099Q",
"rxcui": "15996",
"inchikey": "RONZAEMNMFQXRA-UHFFFAOYSA-N",
"display_name": "MIRTAZAPINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"bb134141-6069-4b86-abac-7783bf5df60d": {
"match": "brand_token",
"title": "MIRTAZAPINE TABLET, FILM COATED [ANI PHARMACEUTICALS, INC.]",
"spl_version": "3",
"published_date": "2026-05-21"
}
},
"productid": "57664-501_f5e842da-4922-4f1d-b2e0-a4c0be71e2a6",
"productndc": "57664-501",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076541",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "001",
"approval_date": "Apr 22, 2004"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "002",
"approval_date": "Apr 22, 2004"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "45MG",
"product_no": "003",
"approval_date": "Apr 22, 2004"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "7.5MG",
"product_no": "004",
"approval_date": "Apr 22, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MIRTAZAPINE",
"proprietary_name": "Mirtazapine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076541",
"marketing_category": "ANDA",
"nonproprietary_name": "Mirtazapine",
"start_marketing_date": "20040422",
"active_numerator_strength": "45"
}Related drugs
Other records sharing ATC code N06AX11.
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