Mirtazapine

Orange BookUNIISPLATC N06AX11

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeN06AX11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6586203101
100 TABLET, FILM COATED in 1 BOTTLE (65862-031-01)
ndc11
6586203105
500 TABLET, FILM COATED in 1 BOTTLE (65862-031-05)
ndc11
6586203130
30 TABLET, FILM COATED in 1 BOTTLE (65862-031-30)
ndc11
6586203132
30 TABLET, FILM COATED in 1 BLISTER PACK (65862-031-32)
ndc11
6586203160
60 TABLET, FILM COATED in 1 BOTTLE (65862-031-60)
ndc11
6586203190
90 TABLET, FILM COATED in 1 BOTTLE (65862-031-90)

Annotations

UNII (FDA Substance ID)

A051Q2099Q

MIRTAZAPINE

RxCUI 15996

Orange Book

A076921

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": "65862-031_e26778b1-5226-4107-9d12-3e8b7038bccc",
  "productndc": "65862-031",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "076921",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "001",
        "approval_date": "Oct 22, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "002",
        "approval_date": "Oct 22, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "003",
        "approval_date": "Oct 22, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "45MG",
        "product_no": "004",
        "approval_date": "Oct 22, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MIRTAZAPINE",
  "proprietary_name": "Mirtazapine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076921",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mirtazapine",
  "start_marketing_date": "20041022",
  "active_numerator_strength": "15"
}

Related drugs

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