mirtazapine

Generic: mirtazapine

Labeler: ncs healthcare of ky, inc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mirtazapine
Generic Name mirtazapine
Labeler ncs healthcare of ky, inc dba vangard labs
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

mirtazapine 15 mg/1

Manufacturer
NCS HealthCare of KY, Inc dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8268
Product ID 0615-8268_bc6ac7f8-bb01-4a98-b809-cdf6964d415d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076921
Listing Expiration 2026-12-31
Marketing Start 2009-08-17

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06158268
Hyphenated Format 0615-8268

Supplemental Identifiers

RxCUI
311725 314111
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 ANDA076921 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8268-05)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8268-39)
source: ndc

Packages (2)

0615-8268-05 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8268-05) 0615-8268-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8268-39)

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": "bc6ac7f8-bb01-4a98-b809-cdf6964d415d", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["311725", "314111"], "spl_set_id": ["20a724c6-feba-40e7-a35a-8a37de2e0136"], "manufacturer_name": ["NCS HealthCare of KY, Inc dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8268-05)", "package_ndc": "0615-8268-05", "marketing_start_date": "20190111"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8268-39)", "package_ndc": "0615-8268-39", "marketing_start_date": "20190111"}], "brand_name": "Mirtazapine", "product_id": "0615-8268_bc6ac7f8-bb01-4a98-b809-cdf6964d415d", "dosage_form": "TABLET, FILM COATED", "product_ndc": "0615-8268", "generic_name": "Mirtazapine", "labeler_name": "NCS HealthCare of KY, Inc dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "15 mg/1"}], "application_number": "ANDA076921", "marketing_category": "ANDA", "marketing_start_date": "20090817", "listing_expiration_date": "20261231"}