REMERON Tablet / Orally disintegrating tablet Ref.[10621] Active ingredients: Mirtazapine

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

REMERON and REMERONSolTab contain mirtazapine. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the empirical formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture:

Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water.

REMERON is available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine Each tablet contains the following inactive ingredients: colloidal silicon dioxide anhydrous, corn starch, ferric oxide (yellow), hydroxypropyl cellulose, hypromellose, magnesium stearate, lactose monohydrate, polyethylene glycol 8000, and titanium dioxide. The 30 mg tablets also contain ferric oxide (red).

REMERONSolTab is available for oral administration as an orally disintegrating tablet containing 15, 30, or 45 mg of mirtazapine. REMERONSolTab also contains the following inactive ingredients: aspartame, citric acid anhydrous fine granular, crospovidone, hypromellose, magnesium stearate, mannitol, granular mannitol 2080, microcrystalline cellulose, natural and artificial orange flavor, polymethacrylate (Eudragit E100), povidone, sodium bicarbonate, and sugar spheres (composed of starch and sucrose).

Dosage Forms and Strengths

REMERON is supplied as:

  • 15 mg tablets: Oval, scored, yellow, with “Organon” debossed on one side and "T3Z" on the other side, on both sides of the score line
  • 15 mg tablets: Oval, scored, yellow, with “MSD” debossed on one side and "T3Z" on the other side, on both sides of the score line
  • 30 mg tablets: Oval, scored, red-brown, with “Organon” debossed on one side and "T5Z" on the other side, on both sides of the score line
  • 30 mg tablets: Oval, scored, red-brown, with “MSD” debossed on one side and "T5Z" on the other side, on both sides of the score line

REMERONSolTab is supplied as:

  • 15 mg orally disintegrating tablets: Round, white, with "T1Z" debossed on one side
  • 30 mg orally disintegrating tablets: Round, white, with "T2Z" debossed on one side
  • 45 mg orally disintegrating tablets: Round, white, with "T4Z" debossed on one side
How Supplied

REMERON tablets are supplied as:

Tablet Strength Tablet Color/Shape Tablet Markings Package Configuration NDC Code
15 mg Yellow, oval tablet Scored with “Organon” debossed on one side and "T3Z" on other side, on both sides of score line Bottle / 30 count 0052-0105-30
15 mg Yellow, oval tablet Scored with “MSD” debossed on one side and "T3Z" on other side, on both sides of score line Bottle / 30 count 0052-4364-01
30 mg Red-brown, oval tablet Scored with “Organon” debossed on one side and "T5Z" on other side, on both sides of score line Bottle / 30 count 0052-0107-30
30 mg Red-brown, oval tablet Scored with “MSD” debossed on one side and "T5Z" on other side, on both sides of score line Bottle / 30 count 0052-4365-01

REMERON SolTab orally disintegrating tablets are supplied as:

Tablet Strength Tablet Color/Shape Tablet Markings Package Configuration NDC Code
15 mg White, round tablet "T1Z" debossed on one side. Box of 5 × 6-unit dose blister packs/ 30 count 0052-0106-30
30 mg White, round tablet "T2Z" debossed on one side. Box of 5 × 6-unit dose blister packs/30 count 0052-0108-30
45 mg White, round tablet " T4Z" debossed on one side Box of 5 × 6-unit dose blister packs/30 count 0052-0110-30

Distributed by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Drugs

Drug Countries
REMERON Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Hong Kong, Italy, Japan, Lithuania, Mexico, Netherlands, Romania, Singapore, Turkey, United States, South Africa
 
Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈