Mirtazapine

Orange BookUNIISPLATC N06AX11

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

Identification

ManufacturerSafecor Health LLC

CountryUS (United States)

ATC codeN06AX11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4843307620
100 BLISTER PACK in 1 CARTON (48433-076-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-076-01)

Annotations

UNII (FDA Substance ID)

A051Q2099Q

MIRTAZAPINE

RxCUI 15996

Orange Book

A076122

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": "48433-076_4c13278f-899f-f1b7-e063-6394a90ac5b7",
  "productndc": "48433-076",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "076122",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Jun 19, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Jun 19, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "45MG",
        "product_no": "003",
        "approval_date": "Jun 19, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MIRTAZAPINE",
  "proprietary_name": "Mirtazapine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076122",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mirtazapine",
  "start_marketing_date": "20260205",
  "active_numerator_strength": "15"
}

Related drugs

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