Mirtazapine

Orange BookUNIISPLATC N06AX11

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

Identification

ManufacturerPrasco Laboratories

CountryUS (United States)

ATC codeN06AX11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6699360804
500 TABLET, FILM COATED in 1 BOTTLE (66993-608-04)
ndc11
6699360830
30 TABLET, FILM COATED in 1 BOTTLE (66993-608-30)

Annotations

UNII (FDA Substance ID)

A051Q2099Q

MIRTAZAPINE

RxCUI 15996

Orange Book

A216751

ABABABAB

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": "66993-608_e1a19354-1c97-49ed-8ec9-bb895dbe69f3",
  "productndc": "66993-608",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "216751",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "001",
        "approval_date": "Jan 18, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "002",
        "approval_date": "Jan 18, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "003",
        "approval_date": "Jan 18, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "45MG",
        "product_no": "004",
        "approval_date": "Jan 18, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MIRTAZAPINE",
  "proprietary_name": "Mirtazapine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216751",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mirtazapine",
  "start_marketing_date": "20230901",
  "active_numerator_strength": "30"
}

Related drugs

Other records sharing ATC code N06AX11.

Access this data programmatically

Query Mirtazapine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs