mirtazapine

Generic: mirtazapine

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

Drug Facts

Product Profile

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

mirtazapine 15 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4322
Product ID 70518-4322_402edcd0-e3d3-bf53-e063-6294a90a7076
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076122
Listing Expiration 2026-12-31
Marketing Start 2025-03-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184322
Hyphenated Format 70518-4322

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 ANDA076122 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4322-0)
source: ndc

Packages (1)

70518-4322-0 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4322-0)

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": "402edcd0-e3d3-bf53-e063-6294a90a7076", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["311725"], "spl_set_id": ["412abf0e-1f96-4d4d-bb56-a23d4699b14c"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4322-0)", "package_ndc": "70518-4322-0", "marketing_start_date": "20250328"}], "brand_name": "Mirtazapine", "product_id": "70518-4322_402edcd0-e3d3-bf53-e063-6294a90a7076", "dosage_form": "TABLET, FILM COATED", "product_ndc": "70518-4322", "generic_name": "Mirtazapine", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "15 mg/1"}], "application_number": "ANDA076122", "marketing_category": "ANDA", "marketing_start_date": "20250328", "listing_expiration_date": "20261231"}