mirtazapine

Generic: mirtazapine

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mirtazapine
Generic Name mirtazapine
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

mirtazapine 30 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 57664-500
Product ID 57664-500_f5e842da-4922-4f1d-b2e0-a4c0be71e2a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076541
Listing Expiration 2026-12-31
Marketing Start 2004-04-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57664500
Hyphenated Format 57664-500

Supplemental Identifiers

RxCUI
311725 311726 314111 476809
UPC
0357664500835
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 ANDA076541 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (57664-500-18)
  • 30 TABLET in 1 BOTTLE (57664-500-83)
source: ndc

Packages (2)

57664-500-18 1000 TABLET in 1 BOTTLE (57664-500-18) 57664-500-83 30 TABLET in 1 BOTTLE (57664-500-83)

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": "f5e842da-4922-4f1d-b2e0-a4c0be71e2a6", "openfda": {"upc": ["0357664500835"], "unii": ["A051Q2099Q"], "rxcui": ["311725", "311726", "314111", "476809"], "spl_set_id": ["f23631be-c7ae-46e9-b771-a70be17bc9f0"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (57664-500-18)", "package_ndc": "57664-500-18", "marketing_start_date": "20040422"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (57664-500-83)", "package_ndc": "57664-500-83", "marketing_start_date": "20040422"}], "brand_name": "Mirtazapine", "product_id": "57664-500_f5e842da-4922-4f1d-b2e0-a4c0be71e2a6", "dosage_form": "TABLET", "product_ndc": "57664-500", "generic_name": "Mirtazapine", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "30 mg/1"}], "application_number": "ANDA076541", "marketing_category": "ANDA", "marketing_start_date": "20040422", "listing_expiration_date": "20261231"}