mirtazapine

Generic: mirtazapine

Labeler: prasco laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mirtazapine
Generic Name mirtazapine
Labeler prasco laboratories
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

mirtazapine 30 mg/1

Manufacturer
Prasco Laboratories

Identifiers & Regulatory

Product NDC 66993-608
Product ID 66993-608_e1a19354-1c97-49ed-8ec9-bb895dbe69f3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216751
Listing Expiration 2026-12-31
Marketing Start 2023-09-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66993608
Hyphenated Format 66993-608

Supplemental Identifiers

RxCUI
311725 311726 314111 476809
UPC
0366993607306 0366993607047 0366993608044
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 ANDA216751 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (66993-608-04)
  • 30 TABLET, FILM COATED in 1 BOTTLE (66993-608-30)
source: ndc

Packages (2)

66993-608-04 500 TABLET, FILM COATED in 1 BOTTLE (66993-608-04) 66993-608-30 30 TABLET, FILM COATED in 1 BOTTLE (66993-608-30)

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": "e1a19354-1c97-49ed-8ec9-bb895dbe69f3", "openfda": {"upc": ["0366993607306", "0366993607047", "0366993608044"], "unii": ["A051Q2099Q"], "rxcui": ["311725", "311726", "314111", "476809"], "spl_set_id": ["8b2a08f7-4803-42fa-a2b5-5ea51f8ef7e4"], "manufacturer_name": ["Prasco Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (66993-608-04)", "package_ndc": "66993-608-04", "marketing_start_date": "20230901"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (66993-608-30)", "package_ndc": "66993-608-30", "marketing_start_date": "20230901"}], "brand_name": "Mirtazapine", "product_id": "66993-608_e1a19354-1c97-49ed-8ec9-bb895dbe69f3", "dosage_form": "TABLET, FILM COATED", "product_ndc": "66993-608", "generic_name": "Mirtazapine", "labeler_name": "Prasco Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "30 mg/1"}], "application_number": "ANDA216751", "marketing_category": "ANDA", "marketing_start_date": "20230901", "listing_expiration_date": "20261231"}