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 71610-100
Product ID 71610-100_b5d04e06-e889-4ccd-97eb-967ec6e00a6c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076921
Listing Expiration 2026-12-31
Marketing Start 2004-10-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610100
Hyphenated Format 71610-100

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 ANDA076921 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (71610-100-15)
  • 45 TABLET, FILM COATED in 1 BOTTLE (71610-100-45)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71610-100-53)
source: ndc

Packages (3)

71610-100-15 15 TABLET, FILM COATED in 1 BOTTLE (71610-100-15) 71610-100-45 45 TABLET, FILM COATED in 1 BOTTLE (71610-100-45) 71610-100-53 60 TABLET, FILM COATED in 1 BOTTLE (71610-100-53)

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": "b5d04e06-e889-4ccd-97eb-967ec6e00a6c", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["314111"], "spl_set_id": ["6ad0e695-92ee-4900-b194-a2455473370b"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71610-100-15)", "package_ndc": "71610-100-15", "marketing_start_date": "20180720"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71610-100-45)", "package_ndc": "71610-100-45", "marketing_start_date": "20180720"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71610-100-53)", "package_ndc": "71610-100-53", "marketing_start_date": "20180720"}], "brand_name": "Mirtazapine", "product_id": "71610-100_b5d04e06-e889-4ccd-97eb-967ec6e00a6c", "dosage_form": "TABLET, FILM COATED", "product_ndc": "71610-100", "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": "ANDA076921", "marketing_category": "ANDA", "marketing_start_date": "20041022", "listing_expiration_date": "20261231"}