mirtazapine

Generic: mirtazapine

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

Drug Facts

Product Profile

Brand Name mirtazapine
Generic Name mirtazapine
Labeler viona pharmaceuticals inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

mirtazapine 15 mg/1

Manufacturer
Viona Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 72578-103
Product ID 72578-103_9ad8f423-a877-4069-8a11-92e1f934974a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205798
Listing Expiration 2026-12-31
Marketing Start 2022-08-07

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72578103
Hyphenated Format 72578-103

Supplemental Identifiers

RxCUI
283406 283407 283485
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 ANDA205798 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 5 BLISTER PACK in 1 CARTON (72578-103-84) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (72578-103-69)
source: ndc

Packages (1)

72578-103-84 5 BLISTER PACK in 1 CARTON (72578-103-84) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (72578-103-69)

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": "9ad8f423-a877-4069-8a11-92e1f934974a", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["283406", "283407", "283485"], "spl_set_id": ["ed491abe-9412-428b-8e24-57242862c99a"], "manufacturer_name": ["Viona Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 CARTON (72578-103-84)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (72578-103-69)", "package_ndc": "72578-103-84", "marketing_start_date": "20220807"}], "brand_name": "Mirtazapine", "product_id": "72578-103_9ad8f423-a877-4069-8a11-92e1f934974a", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "product_ndc": "72578-103", "generic_name": "Mirtazapine", "labeler_name": "Viona Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "15 mg/1"}], "application_number": "ANDA205798", "marketing_category": "ANDA", "marketing_start_date": "20220807", "listing_expiration_date": "20261231"}