Mirtazapine

Orange BookUNIISPLATC N06AX11

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMcKesson Corporation dba SKY Packaging

CountryUS (United States)

ATC codeN06AX11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6373909810
10 BLISTER PACK in 1 BOX (63739-098-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

A051Q2099Q

MIRTAZAPINE

RxCUI 15996

Orange Book

A077666

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": "63739-098_2bb25f3c-7005-6710-e063-6294a90a022c",
  "productndc": "63739-098",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077666",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Aug 22, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Aug 22, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "45MG",
        "product_no": "003",
        "approval_date": "Aug 22, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MIRTAZAPINE",
  "proprietary_name": "Mirtazapine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077666",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mirtazapine",
  "start_marketing_date": "20070822",
  "active_numerator_strength": "15"
}

Related drugs

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