mirtazapine

Generic: mirtazapine

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

mirtazapine 30 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 57237-009
Product ID 57237-009_7616f3f3-c42e-474d-b201-0235120cff36
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076921
Listing Expiration 2026-12-31
Marketing Start 2004-10-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57237009
Hyphenated Format 57237-009

Supplemental Identifiers

RxCUI
311725 311726 314111 476809
UPC
0357237007303
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 ANDA076921 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (57237-009-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (57237-009-30)
source: ndc

Packages (2)

57237-009-05 500 TABLET, FILM COATED in 1 BOTTLE (57237-009-05) 57237-009-30 30 TABLET, FILM COATED in 1 BOTTLE (57237-009-30)

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": "7616f3f3-c42e-474d-b201-0235120cff36", "openfda": {"upc": ["0357237007303"], "unii": ["A051Q2099Q"], "rxcui": ["311725", "311726", "314111", "476809"], "spl_set_id": ["58e9b4c6-531f-49c4-a640-6953e70892fe"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (57237-009-05)", "package_ndc": "57237-009-05", "marketing_start_date": "20041022"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (57237-009-30)", "package_ndc": "57237-009-30", "marketing_start_date": "20041022"}], "brand_name": "Mirtazapine", "product_id": "57237-009_7616f3f3-c42e-474d-b201-0235120cff36", "dosage_form": "TABLET, FILM COATED", "product_ndc": "57237-009", "generic_name": "Mirtazapine", "labeler_name": "Rising Pharma Holdings, Inc.", "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": "20261231"}