mirtazapine

Generic: mirtazapine

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

Drug Facts

Product Profile

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

mirtazapine 30 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4989
Product ID 68071-4989_1b305c50-b2f3-6e01-e063-6394a90a0ce1
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 680714989
Hyphenated Format 68071-4989

Supplemental Identifiers

RxCUI
314111
UPC
0368071498936
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 (68071-4989-3)
source: ndc

Packages (1)

68071-4989-3 30 TABLET, FILM COATED in 1 BOTTLE (68071-4989-3)

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": "1b305c50-b2f3-6e01-e063-6394a90a0ce1", "openfda": {"upc": ["0368071498936"], "unii": ["A051Q2099Q"], "rxcui": ["314111"], "spl_set_id": ["8e839bb2-2f67-f224-e053-2a95a90ae5d8"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68071-4989-3)", "package_ndc": "68071-4989-3", "marketing_start_date": "20190725"}], "brand_name": "Mirtazapine", "product_id": "68071-4989_1b305c50-b2f3-6e01-e063-6394a90a0ce1", "dosage_form": "TABLET, FILM COATED", "product_ndc": "68071-4989", "generic_name": "Mirtazapine", "labeler_name": "NuCare Pharmaceuticals,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"}