mirtazapine

Generic: mirtazapine

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mirtazapine
Generic Name mirtazapine
Labeler avkare
Dosage Form TABLET
Routes
ORAL
Active Ingredients

mirtazapine 7.5 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-494
Product ID 42291-494_3f7cebc7-2ea8-12e2-e063-6394a90abdc6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076541
Listing Expiration 2026-12-31
Marketing Start 2022-08-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291494
Hyphenated Format 42291-494

Supplemental Identifiers

RxCUI
476809
UPC
0342291494909
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 ANDA076541 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (42291-494-30)
  • 90 TABLET in 1 BOTTLE (42291-494-90)
source: ndc

Packages (2)

42291-494-30 30 TABLET in 1 BOTTLE (42291-494-30) 42291-494-90 90 TABLET in 1 BOTTLE (42291-494-90)

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": "3f7cebc7-2ea8-12e2-e063-6394a90abdc6", "openfda": {"upc": ["0342291494909"], "unii": ["A051Q2099Q"], "rxcui": ["476809"], "spl_set_id": ["e5478a6a-a29a-9f61-e053-2995a90a11d0"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (42291-494-30)", "package_ndc": "42291-494-30", "marketing_start_date": "20220802"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (42291-494-90)", "package_ndc": "42291-494-90", "marketing_start_date": "20250923"}], "brand_name": "Mirtazapine", "product_id": "42291-494_3f7cebc7-2ea8-12e2-e063-6394a90abdc6", "dosage_form": "TABLET", "product_ndc": "42291-494", "generic_name": "Mirtazapine", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "7.5 mg/1"}], "application_number": "ANDA076541", "marketing_category": "ANDA", "marketing_start_date": "20220802", "listing_expiration_date": "20261231"}