mirtazapine

Generic: mirtazapine

Labeler: square pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mirtazapine
Generic Name mirtazapine
Labeler square pharmaceuticals limited
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

mirtazapine 15 mg/1

Manufacturer
SQUARE PHARMACEUTICALS LIMITED

Identifiers & Regulatory

Product NDC 76483-110
Product ID 76483-110_d6b98cf3-2e20-47c1-bb31-e8dd31f67cdf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205798
Listing Expiration 2026-12-31
Marketing Start 2022-11-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76483110
Hyphenated Format 76483-110

Supplemental Identifiers

RxCUI
283406 283407 283485
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 ANDA205798 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 TABLET, ORALLY DISINTEGRATING in 1 CARTON (76483-110-00)
source: ndc

Packages (1)

76483-110-00 30 TABLET, ORALLY DISINTEGRATING in 1 CARTON (76483-110-00)

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": "d6b98cf3-2e20-47c1-bb31-e8dd31f67cdf", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["283406", "283407", "283485"], "spl_set_id": ["83093852-d212-408e-98fd-33f4603a9d65"], "manufacturer_name": ["SQUARE PHARMACEUTICALS LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 CARTON (76483-110-00)", "package_ndc": "76483-110-00", "marketing_start_date": "20221115"}], "brand_name": "Mirtazapine", "product_id": "76483-110_d6b98cf3-2e20-47c1-bb31-e8dd31f67cdf", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "product_ndc": "76483-110", "generic_name": "Mirtazapine", "labeler_name": "SQUARE PHARMACEUTICALS LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "15 mg/1"}], "application_number": "ANDA205798", "marketing_category": "ANDA", "marketing_start_date": "20221115", "listing_expiration_date": "20261231"}