mirtazapine

Generic: mirtazapine

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mirtazapine
Generic Name mirtazapine
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

mirtazapine 45 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8459
Product ID 68788-8459_36a45881-20c0-4364-b413-98d54eb1909f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076921
Listing Expiration 2026-12-31
Marketing Start 2023-06-14

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888459
Hyphenated Format 68788-8459

Supplemental Identifiers

RxCUI
311726
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
  • 45 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8459-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8459-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8459-9)
source: ndc

Packages (3)

68788-8459-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8459-3) 68788-8459-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8459-6) 68788-8459-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8459-9)

Ingredients (1)

mirtazapine (45 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": "36a45881-20c0-4364-b413-98d54eb1909f", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["311726"], "spl_set_id": ["2a0689ae-5650-42d1-ac9d-56dd2b467727"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8459-3)", "package_ndc": "68788-8459-3", "marketing_start_date": "20230614"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8459-6)", "package_ndc": "68788-8459-6", "marketing_start_date": "20230614"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8459-9)", "package_ndc": "68788-8459-9", "marketing_start_date": "20230614"}], "brand_name": "Mirtazapine", "product_id": "68788-8459_36a45881-20c0-4364-b413-98d54eb1909f", "dosage_form": "TABLET, FILM COATED", "product_ndc": "68788-8459", "generic_name": "Mirtazapine", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "45 mg/1"}], "application_number": "ANDA076921", "marketing_category": "ANDA", "marketing_start_date": "20230614", "listing_expiration_date": "20261231"}