mirtazapine

Generic: mirtazapine

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

mirtazapine 15 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6519
Product ID 0904-6519_2c3b820d-5318-42f7-b94e-2a70d659af71
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077666
Listing Expiration 2026-12-31
Marketing Start 2007-08-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046519
Hyphenated Format 0904-6519

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
  • 100 BLISTER PACK in 1 CARTON (0904-6519-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6519-61 100 BLISTER PACK in 1 CARTON (0904-6519-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "2c3b820d-5318-42f7-b94e-2a70d659af71", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["311725"], "spl_set_id": ["a80463be-f2d2-4074-9bd8-5e52b0832b3a"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6519-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6519-61", "marketing_start_date": "20070822"}], "brand_name": "Mirtazapine", "product_id": "0904-6519_2c3b820d-5318-42f7-b94e-2a70d659af71", "dosage_form": "TABLET, FILM COATED", "product_ndc": "0904-6519", "generic_name": "Mirtazapine", "labeler_name": "Major Pharmaceuticals", "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": "20070822", "listing_expiration_date": "20261231"}