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United States · US · US:71335-0441_ecc9d098-2d04-4636-a062-ee78eb087819

Mirtazapine

Orange BookUNIISPLATC N06AX11

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN06AX11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    7133504411
    30 TABLET in 1 BOTTLE (71335-0441-1)
  • ndc11
    7133504412
    56 TABLET in 1 BOTTLE (71335-0441-2)
  • ndc11
    7133504413
    15 TABLET in 1 BOTTLE (71335-0441-3)
  • ndc11
    7133504414
    90 TABLET in 1 BOTTLE (71335-0441-4)
  • ndc11
    7133504415
    60 TABLET in 1 BOTTLE (71335-0441-5)
  • ndc11
    7133504416
    28 TABLET in 1 BOTTLE (71335-0441-6)

Annotations

UNII (FDA Substance ID)
A051Q2099Q
MIRTAZAPINE
RxCUI 15996
Orange Book
A076541
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": "71335-0441_ecc9d098-2d04-4636-a062-ee78eb087819",
  "productndc": "71335-0441",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076541",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Apr 22, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Apr 22, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "45MG",
        "product_no": "003",
        "approval_date": "Apr 22, 2004"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "004",
        "approval_date": "Apr 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": "ANDA076541",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mirtazapine",
  "start_marketing_date": "20040422",
  "active_numerator_strength": "30"
}

Related drugs

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