mirtazapine

Generic: mirtazapine

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

Drug Facts

Product Profile

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

mirtazapine 45 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-3545
Product ID 0378-3545_681d9ec4-046b-4c0e-b85f-2468620c724b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076122
Listing Expiration 2026-12-31
Marketing Start 2003-06-20

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03783545
Hyphenated Format 0378-3545

Supplemental Identifiers

RxCUI
311725 311726 314111
UPC
0303783545936 0303783530932
UNII
A051Q2099Q

Packaging Origin

Original Packager
true

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
  • 45 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3545-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3545-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3545-93)
source: ndc

Packages (3)

0378-3545-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3545-01) 0378-3545-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3545-05) 0378-3545-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3545-93)

Ingredients (1)

mirtazapine (45 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": "681d9ec4-046b-4c0e-b85f-2468620c724b", "openfda": {"upc": ["0303783545936", "0303783530932"], "unii": ["A051Q2099Q"], "rxcui": ["311725", "311726", "314111"], "spl_set_id": ["711aa80b-8fc6-49e6-9494-3db31d9b53a4"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3545-01)", "package_ndc": "0378-3545-01", "marketing_start_date": "20160802"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3545-05)", "package_ndc": "0378-3545-05", "marketing_start_date": "20030620"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3545-93)", "package_ndc": "0378-3545-93", "marketing_start_date": "20030620"}], "brand_name": "Mirtazapine", "product_id": "0378-3545_681d9ec4-046b-4c0e-b85f-2468620c724b", "dosage_form": "TABLET, FILM COATED", "product_ndc": "0378-3545", "generic_name": "Mirtazapine", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "45 mg/1"}], "application_number": "ANDA076122", "marketing_category": "ANDA", "marketing_start_date": "20030620", "listing_expiration_date": "20261231"}