mirtazapine

Generic: mirtazapine

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mirtazapine
Generic Name mirtazapine
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

mirtazapine 30 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-378
Product ID 43353-378_1bf61730-9fb6-49cb-e063-6394a90a3b21
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 43353378
Hyphenated Format 43353-378

Supplemental Identifiers

RxCUI
314111
UNII
A051Q2099Q

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
  • 30 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (43353-378-15)
  • 30 TABLET, FILM COATED in 1 BOTTLE (43353-378-30)
  • 45 TABLET, FILM COATED in 1 BOTTLE (43353-378-45)
  • 90 TABLET, FILM COATED in 1 BOTTLE (43353-378-60)
source: ndc

Packages (4)

43353-378-15 15 TABLET, FILM COATED in 1 BOTTLE (43353-378-15) 43353-378-30 30 TABLET, FILM COATED in 1 BOTTLE (43353-378-30) 43353-378-45 45 TABLET, FILM COATED in 1 BOTTLE (43353-378-45) 43353-378-60 90 TABLET, FILM COATED in 1 BOTTLE (43353-378-60)

Ingredients (1)

mirtazapine (30 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": "1bf61730-9fb6-49cb-e063-6394a90a3b21", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["314111"], "spl_set_id": ["ac976282-fb68-4db0-912a-28f075b0716c"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (43353-378-15)", "package_ndc": "43353-378-15", "marketing_start_date": "20180810"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (43353-378-30)", "package_ndc": "43353-378-30", "marketing_start_date": "20180810"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (43353-378-45)", "package_ndc": "43353-378-45", "marketing_start_date": "20180810"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (43353-378-60)", "package_ndc": "43353-378-60", "marketing_start_date": "20240628"}], "brand_name": "Mirtazapine", "product_id": "43353-378_1bf61730-9fb6-49cb-e063-6394a90a3b21", "dosage_form": "TABLET, FILM COATED", "product_ndc": "43353-378", "generic_name": "Mirtazapine", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "30 mg/1"}], "application_number": "ANDA077666", "marketing_category": "ANDA", "marketing_start_date": "20070822", "listing_expiration_date": "20261231"}