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
Routes
ORAL
Active Ingredients

mirtazapine 30 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-713
Product ID 71610-713_f2e7c35d-7c1f-47c3-9879-0ab71aa7a869
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076541
Listing Expiration 2026-12-31
Marketing Start 2004-04-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610713
Hyphenated Format 71610-713

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 ANDA076541 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE (71610-713-15)
  • 45 TABLET in 1 BOTTLE (71610-713-45)
source: ndc

Packages (2)

71610-713-15 15 TABLET in 1 BOTTLE (71610-713-15) 71610-713-45 45 TABLET in 1 BOTTLE (71610-713-45)

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": "f2e7c35d-7c1f-47c3-9879-0ab71aa7a869", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["314111"], "spl_set_id": ["50ccc34a-4b89-4b07-b153-6c71c6924db1"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE (71610-713-15)", "package_ndc": "71610-713-15", "marketing_start_date": "20230605"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-713-45)", "package_ndc": "71610-713-45", "marketing_start_date": "20230605"}], "brand_name": "Mirtazapine", "product_id": "71610-713_f2e7c35d-7c1f-47c3-9879-0ab71aa7a869", "dosage_form": "TABLET", "product_ndc": "71610-713", "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": "ANDA076541", "marketing_category": "ANDA", "marketing_start_date": "20040422", "listing_expiration_date": "20261231"}