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United States · US · US:50090-2558_1227fedd-ff4c-4393-aa32-73ad0b8424b4
Mirtazapine
Orange BookUNIISPLATC N06AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeN06AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11500902558030 TABLET, FILM COATED in 1 BOTTLE (50090-2558-0)
- ndc11500902558260 TABLET, FILM COATED in 1 BOTTLE (50090-2558-2)
- ndc11500902558390 TABLET, FILM COATED in 1 BOTTLE (50090-2558-3)
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": "50090-2558_1227fedd-ff4c-4393-aa32-73ad0b8424b4",
"productndc": "50090-2558",
"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": "20041022",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code N06AX11.
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