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, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

mirtazapine 45 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 57237-013
Product ID 57237-013_ed2cd1df-697f-4e63-8097-7802be5eb6bb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077376
Listing Expiration 2026-12-31
Marketing Start 2006-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57237013
Hyphenated Format 57237-013

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 ANDA077376 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 45 mg/1
source: ndc
Packaging
  • 5 BLISTER PACK in 1 CARTON (57237-013-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
source: ndc

Packages (1)

57237-013-06 5 BLISTER PACK in 1 CARTON (57237-013-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

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": "ed2cd1df-697f-4e63-8097-7802be5eb6bb", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["283406", "283407", "283485"], "spl_set_id": ["73b7bbd9-7dba-4559-890f-3f8dd821e215"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 CARTON (57237-013-06)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "57237-013-06", "marketing_start_date": "20060228"}], "brand_name": "Mirtazapine", "product_id": "57237-013_ed2cd1df-697f-4e63-8097-7802be5eb6bb", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "product_ndc": "57237-013", "generic_name": "Mirtazapine", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "45 mg/1"}], "application_number": "ANDA077376", "marketing_category": "ANDA", "marketing_start_date": "20060228", "listing_expiration_date": "20261231"}