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United States · US · US:63629-3346_1442b48d-d03d-40ee-a846-e8bc71c3f121
Mirtazapine
Orange BookUNIISPLATC N06AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN06AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11636293346130 TABLET, FILM COATED in 1 BOTTLE (63629-3346-1)
- ndc11636293346290 TABLET, FILM COATED in 1 BOTTLE (63629-3346-2)
- ndc11636293346360 TABLET, FILM COATED in 1 BOTTLE (63629-3346-3)
- ndc11636293346428 TABLET, FILM COATED in 1 BOTTLE (63629-3346-4)
Annotations
UNII (FDA Substance ID)
A051Q2099Q
MIRTAZAPINE
RxCUI 15996
Orange Book
A076921
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": "63629-3346_1442b48d-d03d-40ee-a846-e8bc71c3f121",
"productndc": "63629-3346",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "076921",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "7.5MG",
"product_no": "001",
"approval_date": "Oct 22, 2004"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "002",
"approval_date": "Oct 22, 2004"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "003",
"approval_date": "Oct 22, 2004"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "45MG",
"product_no": "004",
"approval_date": "Oct 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": "ANDA076921",
"marketing_category": "ANDA",
"nonproprietary_name": "Mirtazapine",
"start_marketing_date": "20090817",
"active_numerator_strength": "45"
}Related drugs
Other records sharing ATC code N06AX11.
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