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United States · US · US:71335-0964_956bdf1e-236a-4ebe-ac0c-f035adf4b4bd

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 · 7

  • ndc11
    7133509641
    30 TABLET, FILM COATED in 1 BOTTLE (71335-0964-1)
  • ndc11
    7133509642
    56 TABLET, FILM COATED in 1 BOTTLE (71335-0964-2)
  • ndc11
    7133509643
    15 TABLET, FILM COATED in 1 BOTTLE (71335-0964-3)
  • ndc11
    7133509644
    90 TABLET, FILM COATED in 1 BOTTLE (71335-0964-4)
  • ndc11
    7133509645
    60 TABLET, FILM COATED in 1 BOTTLE (71335-0964-5)
  • ndc11
    7133509646
    28 TABLET, FILM COATED in 1 BOTTLE (71335-0964-6)
  • ndc11
    7133509647
    45 TABLET, FILM COATED in 1 BOTTLE (71335-0964-7)

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": "71335-0964_956bdf1e-236a-4ebe-ac0c-f035adf4b4bd",
  "productndc": "71335-0964",
  "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": "30"
}

Related drugs

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