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United States · US · US:57237-011_ed2cd1df-697f-4e63-8097-7802be5eb6bb
Mirtazapine
Orange BookUNIISPLATC N06AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeN06AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1157237011065 BLISTER PACK in 1 CARTON (57237-011-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
A051Q2099Q
MIRTAZAPINE
RxCUI 15996
Orange Book
A077376
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": "57237-011_ed2cd1df-697f-4e63-8097-7802be5eb6bb",
"productndc": "57237-011",
"dosage_form": "TABLET, ORALLY DISINTEGRATING",
"orange_book": {
"appl_no": "077376",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "002",
"approval_date": "Dec 8, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "003",
"approval_date": "Dec 8, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "45MG",
"product_no": "004",
"approval_date": "Feb 28, 2006"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MIRTAZAPINE",
"proprietary_name": "Mirtazapine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077376",
"marketing_category": "ANDA",
"nonproprietary_name": "Mirtazapine",
"start_marketing_date": "20051208",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code N06AX11.
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