mirtazapine

Generic: mirtazapine

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

mirtazapine 30 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-626
Product ID 72189-626_3699b988-6d9b-dcc1-e063-6394a90ab38d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076921
Listing Expiration 2026-12-31
Marketing Start 2025-06-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189626
Hyphenated Format 72189-626

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 ANDA076921 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (72189-626-30)
source: ndc

Packages (1)

72189-626-30 30 TABLET, FILM COATED in 1 BOTTLE (72189-626-30)

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": "3699b988-6d9b-dcc1-e063-6394a90ab38d", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["314111"], "spl_set_id": ["3699b988-6d9a-dcc1-e063-6394a90ab38d"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72189-626-30)", "package_ndc": "72189-626-30", "marketing_start_date": "20250602"}], "brand_name": "Mirtazapine", "product_id": "72189-626_3699b988-6d9b-dcc1-e063-6394a90ab38d", "dosage_form": "TABLET, FILM COATED", "product_ndc": "72189-626", "generic_name": "Mirtazapine", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "30 mg/1"}], "application_number": "ANDA076921", "marketing_category": "ANDA", "marketing_start_date": "20250602", "listing_expiration_date": "20261231"}