mirtazapine

Generic: mirtazapine

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mirtazapine
Generic Name mirtazapine
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

mirtazapine 7.5 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-584
Product ID 60687-584_2b24b256-28e5-28e1-e063-6294a90a8d89
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076921
Listing Expiration 2026-12-31
Marketing Start 2022-08-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687584
Hyphenated Format 60687-584

Supplemental Identifiers

RxCUI
476809
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
  • 7.5 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-584-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-584-11)
source: ndc

Packages (1)

60687-584-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-584-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-584-11)

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": "2b24b256-28e5-28e1-e063-6294a90a8d89", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["476809"], "spl_set_id": ["3b7a5f44-8da6-4196-bb5d-8d2770af1b3a"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-584-21)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-584-11)", "package_ndc": "60687-584-21", "marketing_start_date": "20220829"}], "brand_name": "Mirtazapine", "product_id": "60687-584_2b24b256-28e5-28e1-e063-6294a90a8d89", "dosage_form": "TABLET, FILM COATED", "product_ndc": "60687-584", "generic_name": "Mirtazapine", "labeler_name": "American Health Packaging", "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": "20220829", "listing_expiration_date": "20261231"}