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United States · US · US:68788-7324_f2bab0cb-5847-4a96-96a8-263dbdecf379
Mirtazapine
Orange BookUNIISPLATC N06AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN06AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11687887324115 TABLET, FILM COATED in 1 BOTTLE (68788-7324-1)
- ndc11687887324330 TABLET, FILM COATED in 1 BOTTLE (68788-7324-3)
- ndc11687887324660 TABLET, FILM COATED in 1 BOTTLE (68788-7324-6)
- ndc11687887324990 TABLET, FILM COATED in 1 BOTTLE (68788-7324-9)
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": "68788-7324_f2bab0cb-5847-4a96-96a8-263dbdecf379",
"productndc": "68788-7324",
"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": "20201123",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code N06AX11.
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