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United States · US · US:78206-158_8b121c7c-9bcd-4504-b789-3f551a0fe514
REMERONSOLTAB
Orange BookUNIIATC N06AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOrganon LLC
CountryUS (United States)
ATC codeN06AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1178206158015 BLISTER PACK in 1 BOX (78206-158-01) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (78206-158-99)
Annotations
UNII (FDA Substance ID)
A051Q2099Q
MIRTAZAPINE
RxCUI 15996
Orange Book
N021208
ABABAB
Raw payload (JSON)
{
"unii": {
"unii": "A051Q2099Q",
"rxcui": "15996",
"inchikey": "RONZAEMNMFQXRA-UHFFFAOYSA-N",
"display_name": "MIRTAZAPINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"productid": "78206-158_8b121c7c-9bcd-4504-b789-3f551a0fe514",
"productndc": "78206-158",
"dosage_form": "TABLET, ORALLY DISINTEGRATING",
"orange_book": {
"appl_no": "021208",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "15MG",
"product_no": "001",
"approval_date": "Jan 12, 2001"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "30MG",
"product_no": "002",
"approval_date": "Jan 12, 2001"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "45MG",
"product_no": "003",
"approval_date": "Jan 12, 2001"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MIRTAZAPINE",
"proprietary_name": "REMERONSOLTAB",
"active_ingred_unit": "mg/1",
"application_number": "NDA021208",
"marketing_category": "NDA",
"nonproprietary_name": "MIRTAZAPINE",
"start_marketing_date": "20210601",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code N06AX11.
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