mirtazapine

Generic: mirtazapine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mirtazapine
Generic Name mirtazapine
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

mirtazapine 7.5 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-001
Product ID 65862-001_e26778b1-5226-4107-9d12-3e8b7038bccc
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 65862001
Hyphenated Format 65862-001

Supplemental Identifiers

RxCUI
311725 311726 314111 476809
UPC
0365862003010 0365862031013 0365862001016
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
  • 7.5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65862-001-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-001-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-001-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (65862-001-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65862-001-90)
source: ndc

Packages (5)

65862-001-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-001-01) 65862-001-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-001-05) 65862-001-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-001-30) 65862-001-60 60 TABLET, FILM COATED in 1 BOTTLE (65862-001-60) 65862-001-90 90 TABLET, FILM COATED in 1 BOTTLE (65862-001-90)

Ingredients (1)

mirtazapine (7.5 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": "e26778b1-5226-4107-9d12-3e8b7038bccc", "openfda": {"upc": ["0365862003010", "0365862031013", "0365862001016"], "unii": ["A051Q2099Q"], "rxcui": ["311725", "311726", "314111", "476809"], "spl_set_id": ["a4c012f0-50b6-42fb-9f06-a14632f23f2e"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-001-01)", "package_ndc": "65862-001-01", "marketing_start_date": "20041022"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-001-05)", "package_ndc": "65862-001-05", "marketing_start_date": "20041022"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-001-30)", "package_ndc": "65862-001-30", "marketing_start_date": "20041022"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (65862-001-60)", "package_ndc": "65862-001-60", "marketing_start_date": "20041022"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65862-001-90)", "package_ndc": "65862-001-90", "marketing_start_date": "20041022"}], "brand_name": "Mirtazapine", "product_id": "65862-001_e26778b1-5226-4107-9d12-3e8b7038bccc", "dosage_form": "TABLET, FILM COATED", "product_ndc": "65862-001", "generic_name": "Mirtazapine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "7.5 mg/1"}], "application_number": "ANDA076921", "marketing_category": "ANDA", "marketing_start_date": "20041022", "listing_expiration_date": "20261231"}