mirtazapine

Generic: mirtazapine

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mirtazapine
Generic Name mirtazapine
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

mirtazapine 30 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-2558
Product ID 50090-2558_1227fedd-ff4c-4393-aa32-73ad0b8424b4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076921
Listing Expiration 2027-12-31
Marketing Start 2004-10-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500902558
Hyphenated Format 50090-2558

Supplemental Identifiers

RxCUI
311725 314111
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 ANDA076921 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-2558-0)
  • 60 TABLET, FILM COATED in 1 BOTTLE (50090-2558-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-2558-3)
source: ndc

Packages (3)

50090-2558-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-2558-0) 50090-2558-2 60 TABLET, FILM COATED in 1 BOTTLE (50090-2558-2) 50090-2558-3 90 TABLET, FILM COATED in 1 BOTTLE (50090-2558-3)

Ingredients (1)

mirtazapine (30 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": "1227fedd-ff4c-4393-aa32-73ad0b8424b4", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["311725", "314111"], "spl_set_id": ["552e2261-53db-4a27-b277-f7b62c3ea2ed"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-2558-0)", "package_ndc": "50090-2558-0", "marketing_start_date": "20170313"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (50090-2558-2)", "package_ndc": "50090-2558-2", "marketing_start_date": "20161216"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-2558-3)", "package_ndc": "50090-2558-3", "marketing_start_date": "20161025"}], "brand_name": "Mirtazapine", "product_id": "50090-2558_1227fedd-ff4c-4393-aa32-73ad0b8424b4", "dosage_form": "TABLET, FILM COATED", "product_ndc": "50090-2558", "generic_name": "Mirtazapine", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "30 mg/1"}], "application_number": "ANDA076921", "marketing_category": "ANDA", "marketing_start_date": "20041022", "listing_expiration_date": "20271231"}