mirtazapine

Generic: mirtazapine

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

mirtazapine 15 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 61919-153
Product ID 61919-153_47e14699-4104-6433-e063-6394a90acbcc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077666
Listing Expiration 2027-12-31
Marketing Start 2022-05-10

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61919153
Hyphenated Format 61919-153

Supplemental Identifiers

RxCUI
311725
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 ANDA077666 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (61919-153-60)
source: ndc

Packages (1)

61919-153-60 60 TABLET, FILM COATED in 1 BOTTLE (61919-153-60)

Ingredients (1)

mirtazapine (15 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": "47e14699-4104-6433-e063-6394a90acbcc", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["311725"], "spl_set_id": ["dea8c09a-b759-1da7-e053-2a95a90a3346"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (61919-153-60)", "package_ndc": "61919-153-60", "marketing_start_date": "20220510"}], "brand_name": "Mirtazapine", "product_id": "61919-153_47e14699-4104-6433-e063-6394a90acbcc", "dosage_form": "TABLET, FILM COATED", "product_ndc": "61919-153", "generic_name": "Mirtazapine", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "15 mg/1"}], "application_number": "ANDA077666", "marketing_category": "ANDA", "marketing_start_date": "20220510", "listing_expiration_date": "20271231"}