mirtazapine

Generic: mirtazapine

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mirtazapine
Generic Name mirtazapine
Labeler apotex corp.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

mirtazapine 45 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-0249
Product ID 60505-0249_c076cd92-b06d-b317-cc04-6f99b3718cf7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077666
Listing Expiration 2026-12-31
Marketing Start 2007-08-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605050249
Hyphenated Format 60505-0249

Supplemental Identifiers

RxCUI
311725 311726 314111
UPC
0360505024711 0360505024810 0360505024919
UNII
A051Q2099Q

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name mirtazapine (source: ndc)
Generic Name mirtazapine (source: ndc)
Application Number ANDA077666 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 45 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (60505-0249-1)
  • 100 TABLET, FILM COATED in 1 BOTTLE (60505-0249-3)
  • 500 TABLET, FILM COATED in 1 BOTTLE (60505-0249-5)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (60505-0249-8)
source: ndc

Packages (4)

60505-0249-1 30 TABLET, FILM COATED in 1 BOTTLE (60505-0249-1) 60505-0249-3 100 TABLET, FILM COATED in 1 BOTTLE (60505-0249-3) 60505-0249-5 500 TABLET, FILM COATED in 1 BOTTLE (60505-0249-5) 60505-0249-8 1000 TABLET, FILM COATED in 1 BOTTLE (60505-0249-8)

Ingredients (1)

mirtazapine (45 mg/1)

Linked Drug Pages (1)

Mirtazapine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c076cd92-b06d-b317-cc04-6f99b3718cf7", "openfda": {"upc": ["0360505024711", "0360505024810", "0360505024919"], "unii": ["A051Q2099Q"], "rxcui": ["311725", "311726", "314111"], "spl_set_id": ["9675333e-3064-c8cb-a4b4-6c74d9a82f17"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (60505-0249-1)", "package_ndc": "60505-0249-1", "marketing_start_date": "20070822"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (60505-0249-3)", "package_ndc": "60505-0249-3", "marketing_start_date": "20070822"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (60505-0249-5)", "package_ndc": "60505-0249-5", "marketing_start_date": "20070822"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (60505-0249-8)", "package_ndc": "60505-0249-8", "marketing_start_date": "20070822"}], "brand_name": "Mirtazapine", "product_id": "60505-0249_c076cd92-b06d-b317-cc04-6f99b3718cf7", "dosage_form": "TABLET, FILM COATED", "product_ndc": "60505-0249", "generic_name": "Mirtazapine", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "45 mg/1"}], "application_number": "ANDA077666", "marketing_category": "ANDA", "marketing_start_date": "20070822", "listing_expiration_date": "20261231"}