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United States · US · US:60505-0249_c076cd92-b06d-b317-cc04-6f99b3718cf7
Mirtazapine
Orange BookUNIISPLATC N06AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp.
CountryUS (United States)
ATC codeN06AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11605050249130 TABLET, FILM COATED in 1 BOTTLE (60505-0249-1)
- ndc116050502493100 TABLET, FILM COATED in 1 BOTTLE (60505-0249-3)
- ndc116050502495500 TABLET, FILM COATED in 1 BOTTLE (60505-0249-5)
- ndc1160505024981000 TABLET, FILM COATED in 1 BOTTLE (60505-0249-8)
Annotations
UNII (FDA Substance ID)
A051Q2099Q
MIRTAZAPINE
RxCUI 15996
Orange Book
A077666
ABABAB
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": "60505-0249_c076cd92-b06d-b317-cc04-6f99b3718cf7",
"productndc": "60505-0249",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "077666",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "001",
"approval_date": "Aug 22, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "002",
"approval_date": "Aug 22, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "45MG",
"product_no": "003",
"approval_date": "Aug 22, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MIRTAZAPINE",
"proprietary_name": "Mirtazapine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077666",
"marketing_category": "ANDA",
"nonproprietary_name": "Mirtazapine",
"start_marketing_date": "20070822",
"active_numerator_strength": "45"
}Related drugs
Other records sharing ATC code N06AX11.
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