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, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

mirtazapine 15 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-021
Product ID 65862-021_04494335-fcd8-47b2-a573-98a214f07ff6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077376
Listing Expiration 2026-12-31
Marketing Start 2005-12-08

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862021
Hyphenated Format 65862-021

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
  • 15 mg/1
source: ndc
Packaging
  • 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-01)
  • 5 BLISTER PACK in 1 CARTON (65862-021-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-30)
  • 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-60)
  • 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-90)
source: ndc

Packages (5)

65862-021-01 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-01) 65862-021-06 5 BLISTER PACK in 1 CARTON (65862-021-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 65862-021-30 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-30) 65862-021-60 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-60) 65862-021-90 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-90)

Ingredients (1)

mirtazapine (15 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": "04494335-fcd8-47b2-a573-98a214f07ff6", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["283406", "283407", "283485"], "spl_set_id": ["3a8a4490-9243-4201-944d-cea27d3d69f5"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-01)", "package_ndc": "65862-021-01", "marketing_start_date": "20051208"}, {"sample": false, "description": "5 BLISTER PACK in 1 CARTON (65862-021-06)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "65862-021-06", "marketing_start_date": "20051208"}, {"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-30)", "package_ndc": "65862-021-30", "marketing_start_date": "20051208"}, {"sample": false, "description": "60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-60)", "package_ndc": "65862-021-60", "marketing_start_date": "20051208"}, {"sample": false, "description": "90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-90)", "package_ndc": "65862-021-90", "marketing_start_date": "20051208"}], "brand_name": "Mirtazapine", "product_id": "65862-021_04494335-fcd8-47b2-a573-98a214f07ff6", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "product_ndc": "65862-021", "generic_name": "Mirtazapine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "15 mg/1"}], "application_number": "ANDA077376", "marketing_category": "ANDA", "marketing_start_date": "20051208", "listing_expiration_date": "20261231"}