mirtazapine

Generic: mirtazapine

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mirtazapine
Generic Name mirtazapine
Labeler avkare
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

mirtazapine 30 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-952
Product ID 42291-952_35923954-c6ec-3d84-e063-6394a90aecf4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077666
Listing Expiration 2026-12-31
Marketing Start 2025-05-20

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291952
Hyphenated Format 42291-952

Supplemental Identifiers

RxCUI
314111
UPC
0342291952508
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 ANDA077666 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (42291-952-50)
source: ndc

Packages (1)

42291-952-50 500 TABLET, FILM COATED in 1 BOTTLE (42291-952-50)

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": "35923954-c6ec-3d84-e063-6394a90aecf4", "openfda": {"upc": ["0342291952508"], "unii": ["A051Q2099Q"], "rxcui": ["314111"], "spl_set_id": ["35922615-7619-3852-e063-6394a90a2e55"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (42291-952-50)", "package_ndc": "42291-952-50", "marketing_start_date": "20250520"}], "brand_name": "Mirtazapine", "product_id": "42291-952_35923954-c6ec-3d84-e063-6394a90aecf4", "dosage_form": "TABLET, FILM COATED", "product_ndc": "42291-952", "generic_name": "Mirtazapine", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "30 mg/1"}], "application_number": "ANDA077666", "marketing_category": "ANDA", "marketing_start_date": "20250520", "listing_expiration_date": "20261231"}