18860-101 : Fazaclo 12.5 mg Disintegrating Tablet


NDC: 18860-101
Labeler: Jazz Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Fazaclo
Dosage Form: Oral Tablet, Orally Disintegrating
Application #: NDA021590
Rev. Date: 


Appearance:


Markings: A05
Shapes:  Round
Colors:  Yellow
Size (mm): 6
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 18860-101-10: 100 TABLET, ORALLY DISINTEGRATING IN 1 BOTTLE (18860‑101‑10)

Active Ingredients:

  • Clozapine

Dosage Strength:

  • 12.5 mg

Inactive Ingredients:

  • Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate Copolymer
  • Mannitol
  • Aspartame
  • Cellulose, Microcrystalline
  • Crospovidone
  • Mint
  • Sodium Bicarbonate
  • Citric Acid Monohydrate
  • Ferric Oxide Yellow
  • Magnesium Stearate

Pharmaceutical Classes:

  • Atypical Antipsychotic [EPC]

Related Products:

Based on records with the same trade name.
  • 18860-102 Fazaclo 25 mg Disintegrating Tablet by Jazz Pharmaceuticals, Inc.
  • 18860-104 Fazaclo 100 mg Disintegrating Tablet by Jazz Pharmaceuticals, Inc.
  • 18860-105 Fazaclo 150 mg Disintegrating Tablet by Jazz Pharmaceuticals, Inc.
  • 18860-106 Fazaclo 200 mg Disintegrating Tablet by Jazz Pharmaceuticals, Inc.

NDC QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.