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 45 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-121
Product ID 68084-121_237f93fe-0241-f4a1-e063-6394a90a2ce9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076921
Listing Expiration 2026-12-31
Marketing Start 2006-01-05

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68084121
Hyphenated Format 68084-121

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 ANDA076921 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 45 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-121-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-121-11)
source: ndc

Packages (1)

68084-121-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-121-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-121-11)

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": "237f93fe-0241-f4a1-e063-6394a90a2ce9", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["311725", "311726", "314111"], "spl_set_id": ["82a615a0-e74a-49cb-9a57-ffbb3df604d5"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-121-01)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-121-11)", "package_ndc": "68084-121-01", "marketing_start_date": "20060105"}], "brand_name": "Mirtazapine", "product_id": "68084-121_237f93fe-0241-f4a1-e063-6394a90a2ce9", "dosage_form": "TABLET, FILM COATED", "product_ndc": "68084-121", "generic_name": "Mirtazapine", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "45 mg/1"}], "application_number": "ANDA076921", "marketing_category": "ANDA", "marketing_start_date": "20060105", "listing_expiration_date": "20261231"}