NDC 18860-101

FazaClo

Clozapine

FazaClo is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Jazz Pharmaceuticals, Inc.. The primary component is Clozapine.

• Product ID: 18860-101_313e175e-dd63-4ba7-b0d7-c0837a5c08a8
• NDC: 18860-101
• Product Type: Human Prescription Drug
• Proprietary Name: FazaClo
• Generic Name: Clozapine
• Dosage Form: Tablet, Orally Disintegrating
• Route of Administration: ORAL
• Marketing Start Date: 2007-07-01
• Marketing End Date: 2021-02-28
• Marketing Category: NDA / NDA
• Application Number: NDA021590
• Labeler Name: Jazz Pharmaceuticals, Inc.
• Substance Name: CLOZAPINE
• Active Ingredient Strength: 13 mg/1
• Pharm Classes: Atypical Antipsychotic [EPC]
• NDC Exclude Flag: N

Packaging

NDC 18860-101-10

100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (18860-101-10)

• Marketing Start Date: 2007-07-01
• Marketing End Date: 2021-02-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 18860-101-10 [18860010110]

FazaClo TABLET, ORALLY DISINTEGRATING

• Marketing Category: NDA
• Application Number: NDA021590
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-07-01
• Marketing End Date: 2021-02-28

Drug Details

Active Ingredients

Ingredient	Strength
CLOZAPINE	12.5 mg/1

OpenFDA Data

• SPL SET ID: b7b7541a-1fe4-4b11-b6b7-68fb5510faa4
• Manufacturer:
  • Jazz Pharmaceuticals, Inc.
• UNII:
  • J60AR2IKIC
• RxNorm Concept Unique ID - RxCUI:
  • 1006801
  • 1006803
  • 996921
  • 476177
  • 721775
  • 542977
  • 996923
  • 721773
  • 543013
  • 476179
• UPC Code:
  • 0318860102100
  • 0318860101103

Pharmacological Class

• Atypical Antipsychotic [EPC]

NDC Crossover Matching brand name "FazaClo" or generic name "Clozapine"

NDC	Brand Name	Generic Name
18860-102	FazaClo	FazaClo
18860-105	FazaClo	FazaClo
18860-104	FazaClo	FazaClo
18860-101	FazaClo	FazaClo
18860-106	FazaClo	FazaClo
0093-3010	Clozapine	clozapine
0093-3011	Clozapine	clozapine
0093-3012	Clozapine	clozapine
0093-3086	Clozapine	clozapine
0093-3087	Clozapine	clozapine
0093-4359	Clozapine	Clozapine
0093-4404	Clozapine	Clozapine
0093-4405	Clozapine	Clozapine
0093-5376	Clozapine	Clozapine
0093-5377	Clozapine	Clozapine