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United States · US · US:65862-023_04494335-fcd8-47b2-a573-98a214f07ff6
Mirtazapine
Orange BookUNIISPLATC N06AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeN06AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116586202301100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-023-01)
- ndc1165862023065 BLISTER PACK in 1 CARTON (65862-023-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
- ndc11658620233030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-023-30)
- ndc11658620236060 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-023-60)
- ndc11658620239090 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-023-90)
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": "65862-023_04494335-fcd8-47b2-a573-98a214f07ff6",
"productndc": "65862-023",
"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": "20060228",
"active_numerator_strength": "45"
}Related drugs
Other records sharing ATC code N06AX11.
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