remeron

Generic: mirtazapine

Labeler: organon llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

mirtazapine 30 mg/1

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-161
Product ID 78206-161_8b121c7c-9bcd-4504-b789-3f551a0fe514
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020415
Listing Expiration 2026-12-31
Marketing Start 2021-06-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 78206161
Hyphenated Format 78206-161

Supplemental Identifiers

RxCUI
211322 211323 283406 283407 283485 311725 314111 752869 752870 752871
UPC
0378206161017 0378206160010
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 remeron (source: ndc)
Generic Name mirtazapine (source: ndc)
Application Number NDA020415 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (78206-161-01)
source: ndc

Packages (1)

78206-161-01 30 TABLET, FILM COATED in 1 BOTTLE (78206-161-01)

Ingredients (1)

mirtazapine (30 mg/1)

Linked Drug Pages (1)

REMERONSOLTAB, REMERON ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8b121c7c-9bcd-4504-b789-3f551a0fe514", "openfda": {"upc": ["0378206161017", "0378206160010"], "unii": ["A051Q2099Q"], "rxcui": ["211322", "211323", "283406", "283407", "283485", "311725", "314111", "752869", "752870", "752871"], "spl_set_id": ["98ad1917-a094-44f5-a28f-a64a8cfcd887"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (78206-161-01)", "package_ndc": "78206-161-01", "marketing_start_date": "20210601"}], "brand_name": "REMERON", "product_id": "78206-161_8b121c7c-9bcd-4504-b789-3f551a0fe514", "dosage_form": "TABLET, FILM COATED", "product_ndc": "78206-161", "generic_name": "MIRTAZAPINE", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "REMERON", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "30 mg/1"}], "application_number": "NDA020415", "marketing_category": "NDA", "marketing_start_date": "20210601", "listing_expiration_date": "20261231"}