mirtazapine

Generic: mirtazapine

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mirtazapine
Generic Name mirtazapine
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

mirtazapine 45 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-471
Product ID 63187-471_fb4bf3e5-f62b-489a-ba75-8e94513f29ca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077666
Listing Expiration 2026-12-31
Marketing Start 2007-08-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187471
Hyphenated Format 63187-471

Supplemental Identifiers

RxCUI
311725 311726
UPC
0363187206307 0363187471309
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
  • 45 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (63187-471-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (63187-471-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (63187-471-90)
source: ndc

Packages (3)

63187-471-30 30 TABLET, FILM COATED in 1 BOTTLE (63187-471-30) 63187-471-60 60 TABLET, FILM COATED in 1 BOTTLE (63187-471-60) 63187-471-90 90 TABLET, FILM COATED in 1 BOTTLE (63187-471-90)

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": "fb4bf3e5-f62b-489a-ba75-8e94513f29ca", "openfda": {"upc": ["0363187206307", "0363187471309"], "unii": ["A051Q2099Q"], "rxcui": ["311725", "311726"], "spl_set_id": ["3b516a33-b164-4e4f-bc18-e9d1e591323a"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63187-471-30)", "package_ndc": "63187-471-30", "marketing_start_date": "20150202"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63187-471-60)", "package_ndc": "63187-471-60", "marketing_start_date": "20150202"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (63187-471-90)", "package_ndc": "63187-471-90", "marketing_start_date": "20150202"}], "brand_name": "Mirtazapine", "product_id": "63187-471_fb4bf3e5-f62b-489a-ba75-8e94513f29ca", "dosage_form": "TABLET, FILM COATED", "product_ndc": "63187-471", "generic_name": "Mirtazapine", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "45 mg/1"}], "application_number": "ANDA077666", "marketing_category": "ANDA", "marketing_start_date": "20070822", "listing_expiration_date": "20261231"}