mirtazapine

Generic: mirtazapine

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

mirtazapine 7.5 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 72603-558
Product ID 72603-558_979eec8b-1bf4-466b-812e-85a111ce1cb5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076921
Listing Expiration 2026-12-31
Marketing Start 2025-04-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603558
Hyphenated Format 72603-558

Supplemental Identifiers

RxCUI
476809
UPC
0372603558012
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 ANDA076921 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (72603-558-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (72603-558-02)
source: ndc

Packages (2)

72603-558-01 30 TABLET, FILM COATED in 1 BOTTLE (72603-558-01) 72603-558-02 500 TABLET, FILM COATED in 1 BOTTLE (72603-558-02)

Ingredients (1)

mirtazapine (7.5 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": "979eec8b-1bf4-466b-812e-85a111ce1cb5", "openfda": {"upc": ["0372603558012"], "unii": ["A051Q2099Q"], "rxcui": ["476809"], "spl_set_id": ["979eec8b-1bf4-466b-812e-85a111ce1cb5"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72603-558-01)", "package_ndc": "72603-558-01", "marketing_start_date": "20250401"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (72603-558-02)", "package_ndc": "72603-558-02", "marketing_start_date": "20250401"}], "brand_name": "Mirtazapine", "product_id": "72603-558_979eec8b-1bf4-466b-812e-85a111ce1cb5", "dosage_form": "TABLET, FILM COATED", "product_ndc": "72603-558", "generic_name": "Mirtazapine", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "7.5 mg/1"}], "application_number": "ANDA076921", "marketing_category": "ANDA", "marketing_start_date": "20250401", "listing_expiration_date": "20261231"}