mirtazapine

Generic: mirtazapine

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

mirtazapine 15 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1590
Product ID 67046-1590_3eed81ad-e8ac-db55-e063-6394a90a054c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077666
Listing Expiration 2026-12-31
Marketing Start 2025-09-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461590
Hyphenated Format 67046-1590

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 ANDA077666 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1590-3)
source: ndc

Packages (1)

67046-1590-3 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1590-3)

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": "3eed81ad-e8ac-db55-e063-6394a90a054c", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["311725"], "spl_set_id": ["3eed8213-a240-fc4b-e063-6294a90a3b05"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1590-3)", "package_ndc": "67046-1590-3", "marketing_start_date": "20250916"}], "brand_name": "Mirtazapine", "product_id": "67046-1590_3eed81ad-e8ac-db55-e063-6394a90a054c", "dosage_form": "TABLET, FILM COATED", "product_ndc": "67046-1590", "generic_name": "Mirtazapine", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "15 mg/1"}], "application_number": "ANDA077666", "marketing_category": "ANDA", "marketing_start_date": "20250916", "listing_expiration_date": "20261231"}