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 71610-853
Product ID 71610-853_2203a8b5-8b63-7fbc-e063-6394a90a879f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216751
Listing Expiration 2026-12-31
Marketing Start 2023-09-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610853
Hyphenated Format 71610-853

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 ANDA216751 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (71610-853-15)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-853-60)
source: ndc

Packages (2)

71610-853-15 15 TABLET, FILM COATED in 1 BOTTLE (71610-853-15) 71610-853-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-853-60)

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": "2203a8b5-8b63-7fbc-e063-6394a90a879f", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["311725"], "spl_set_id": ["20eafce1-50cd-0d9c-e063-6394a90ad6fe"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71610-853-15)", "package_ndc": "71610-853-15", "marketing_start_date": "20240912"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-853-60)", "package_ndc": "71610-853-60", "marketing_start_date": "20240829"}], "brand_name": "Mirtazapine", "product_id": "71610-853_2203a8b5-8b63-7fbc-e063-6394a90a879f", "dosage_form": "TABLET, FILM COATED", "product_ndc": "71610-853", "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": "ANDA216751", "marketing_category": "ANDA", "marketing_start_date": "20230901", "listing_expiration_date": "20261231"}