mirtazapine

Generic: mirtazapine

Labeler: mylan institutional inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

mirtazapine 45 mg/1

Manufacturer
Mylan Institutional Inc.

Identifiers & Regulatory

Product NDC 51079-088
Product ID 51079-088_3a87423c-fbbb-b2a4-e063-6394a90a0db3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076122
Listing Expiration 2026-12-31
Marketing Start 2003-08-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51079088
Hyphenated Format 51079-088

Supplemental Identifiers

RxCUI
311725 311726 314111
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 ANDA076122 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 45 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (51079-088-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-088-01)
source: ndc

Packages (1)

51079-088-20 100 BLISTER PACK in 1 CARTON (51079-088-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-088-01)

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": "3a87423c-fbbb-b2a4-e063-6394a90a0db3", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["311725", "311726", "314111"], "spl_set_id": ["6837b69b-2f86-42cf-b48d-b4a3c7b5413f"], "manufacturer_name": ["Mylan Institutional Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (51079-088-20)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-088-01)", "package_ndc": "51079-088-20", "marketing_start_date": "20030801"}], "brand_name": "Mirtazapine", "product_id": "51079-088_3a87423c-fbbb-b2a4-e063-6394a90a0db3", "dosage_form": "TABLET, FILM COATED", "product_ndc": "51079-088", "generic_name": "Mirtazapine", "labeler_name": "Mylan Institutional Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "45 mg/1"}], "application_number": "ANDA076122", "marketing_category": "ANDA", "marketing_start_date": "20030801", "listing_expiration_date": "20261231"}