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 71610-523
Product ID 71610-523_622e1f6b-89f8-4ade-ac9f-cebcf8d94aea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076122
Listing Expiration 2026-12-31
Marketing Start 2003-06-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610523
Hyphenated Format 71610-523

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 ANDA076122 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-523-15)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-523-30)
  • 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-523-45)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-523-53)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-523-60)
source: ndc

Packages (5)

71610-523-15 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-523-15) 71610-523-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-523-30) 71610-523-45 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-523-45) 71610-523-53 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-523-53) 71610-523-60 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-523-60)

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": "622e1f6b-89f8-4ade-ac9f-cebcf8d94aea", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["314111"], "spl_set_id": ["500dbfbe-2a00-496d-9e44-6e59d2c68ea2"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-523-15)", "package_ndc": "71610-523-15", "marketing_start_date": "20210423"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-523-30)", "package_ndc": "71610-523-30", "marketing_start_date": "20210203"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-523-45)", "package_ndc": "71610-523-45", "marketing_start_date": "20210423"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-523-53)", "package_ndc": "71610-523-53", "marketing_start_date": "20210804"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-523-60)", "package_ndc": "71610-523-60", "marketing_start_date": "20210212"}], "brand_name": "Mirtazapine", "product_id": "71610-523_622e1f6b-89f8-4ade-ac9f-cebcf8d94aea", "dosage_form": "TABLET, FILM COATED", "product_ndc": "71610-523", "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": "ANDA076122", "marketing_category": "ANDA", "marketing_start_date": "20030619", "listing_expiration_date": "20261231"}