mirtazapine

Generic: mirtazapine

Labeler: aurolife pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

mirtazapine 30 mg/1

Manufacturer
Aurolife Pharma LLC

Identifiers & Regulatory

Product NDC 13107-003
Product ID 13107-003_4329eeed-8071-4b6c-887d-0cd00647b84c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076921
Listing Expiration 2026-12-31
Marketing Start 2009-08-17

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13107003
Hyphenated Format 13107-003

Supplemental Identifiers

RxCUI
311725 311726 314111 476809
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
  • 100 TABLET, FILM COATED in 1 BOTTLE (13107-003-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (13107-003-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (13107-003-30)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (13107-003-32)
  • 30 TABLET, FILM COATED in 1 BOTTLE (13107-003-34)
  • 60 TABLET, FILM COATED in 1 BOTTLE (13107-003-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (13107-003-90)
source: ndc

Packages (7)

13107-003-01 100 TABLET, FILM COATED in 1 BOTTLE (13107-003-01) 13107-003-05 500 TABLET, FILM COATED in 1 BOTTLE (13107-003-05) 13107-003-30 30 TABLET, FILM COATED in 1 BOTTLE (13107-003-30) 13107-003-32 30 TABLET, FILM COATED in 1 BLISTER PACK (13107-003-32) 13107-003-34 30 TABLET, FILM COATED in 1 BOTTLE (13107-003-34) 13107-003-60 60 TABLET, FILM COATED in 1 BOTTLE (13107-003-60) 13107-003-90 90 TABLET, FILM COATED in 1 BOTTLE (13107-003-90)

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": "4329eeed-8071-4b6c-887d-0cd00647b84c", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["311725", "311726", "314111", "476809"], "spl_set_id": ["aa05d606-29fd-443e-802b-1d65584d6bb1"], "manufacturer_name": ["Aurolife Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (13107-003-01)", "package_ndc": "13107-003-01", "marketing_start_date": "20090817"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (13107-003-05)", "package_ndc": "13107-003-05", "marketing_start_date": "20090817"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (13107-003-30)", "package_ndc": "13107-003-30", "marketing_start_date": "20090817"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (13107-003-32)", "package_ndc": "13107-003-32", "marketing_start_date": "20090817"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (13107-003-34)", "package_ndc": "13107-003-34", "marketing_start_date": "20090817"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (13107-003-60)", "package_ndc": "13107-003-60", "marketing_start_date": "20090817"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (13107-003-90)", "package_ndc": "13107-003-90", "marketing_start_date": "20090817"}], "brand_name": "Mirtazapine", "product_id": "13107-003_4329eeed-8071-4b6c-887d-0cd00647b84c", "dosage_form": "TABLET, FILM COATED", "product_ndc": "13107-003", "generic_name": "Mirtazapine", "labeler_name": "Aurolife Pharma LLC", "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": "20090817", "listing_expiration_date": "20261231"}