mirtazapine

Generic: mirtazapine

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mirtazapine
Generic Name mirtazapine
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

mirtazapine 15 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0305
Product ID 80425-0305_2a9ba8f4-6cee-e827-e063-6394a90a0300
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076921
Listing Expiration 2026-12-31
Marketing Start 2023-04-07

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250305
Hyphenated Format 80425-0305

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 ANDA076921 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (80425-0305-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (80425-0305-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (80425-0305-3)
source: ndc

Packages (3)

80425-0305-1 30 TABLET, FILM COATED in 1 BOTTLE (80425-0305-1) 80425-0305-2 60 TABLET, FILM COATED in 1 BOTTLE (80425-0305-2) 80425-0305-3 90 TABLET, FILM COATED in 1 BOTTLE (80425-0305-3)

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": "2a9ba8f4-6cee-e827-e063-6394a90a0300", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["311725"], "spl_set_id": ["f8c383c1-d1b3-ceaa-e053-6294a90a6053"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (80425-0305-1)", "package_ndc": "80425-0305-1", "marketing_start_date": "20230407"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (80425-0305-2)", "package_ndc": "80425-0305-2", "marketing_start_date": "20230407"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (80425-0305-3)", "package_ndc": "80425-0305-3", "marketing_start_date": "20230407"}], "brand_name": "Mirtazapine", "product_id": "80425-0305_2a9ba8f4-6cee-e827-e063-6394a90a0300", "dosage_form": "TABLET, FILM COATED", "product_ndc": "80425-0305", "generic_name": "Mirtazapine", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "15 mg/1"}], "application_number": "ANDA076921", "marketing_category": "ANDA", "marketing_start_date": "20230407", "listing_expiration_date": "20261231"}