Mirtazapine

Orange BookUNIISPLATC N06AX11

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeN06AX11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7161085315
15 TABLET, FILM COATED in 1 BOTTLE (71610-853-15)
ndc11
7161085360
90 TABLET, FILM COATED in 1 BOTTLE (71610-853-60)

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": "71610-853_2203a8b5-8b63-7fbc-e063-6394a90a879f",
  "productndc": "71610-853",
  "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": "15"
}

Related drugs

Other records sharing ATC code N06AX11.

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