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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

  • ndc11
    7820615801
    5 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

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