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 15 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-475
Product ID 71610-475_a6847321-3e41-463d-92b0-b8186e0269ca
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 71610475
Hyphenated Format 71610-475

Supplemental Identifiers

RxCUI
311725
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
  • 15 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-475-15)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-475-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-475-60)
source: ndc

Packages (3)

71610-475-15 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-475-15) 71610-475-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-475-30) 71610-475-60 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-475-60)

Ingredients (1)

mirtazapine (15 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": "a6847321-3e41-463d-92b0-b8186e0269ca", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["311725"], "spl_set_id": ["93c4ddcf-ca4f-4a46-a7b7-1395fb0885d2"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-475-15)", "package_ndc": "71610-475-15", "marketing_start_date": "20201023"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-475-30)", "package_ndc": "71610-475-30", "marketing_start_date": "20201015"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-475-60)", "package_ndc": "71610-475-60", "marketing_start_date": "20201023"}], "brand_name": "Mirtazapine", "product_id": "71610-475_a6847321-3e41-463d-92b0-b8186e0269ca", "dosage_form": "TABLET, FILM COATED", "product_ndc": "71610-475", "generic_name": "Mirtazapine", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "15 mg/1"}], "application_number": "ANDA076122", "marketing_category": "ANDA", "marketing_start_date": "20030619", "listing_expiration_date": "20261231"}