NDC 18860-121

VERSACLOZ

Clozapine

VERSACLOZ is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Jazz Pharmaceuticals, Inc.. The primary component is Clozapine.

• Product ID: 18860-121_f7d4b279-d9de-4fb3-b67c-24e2b4d39b50
• NDC: 18860-121
• Product Type: Human Prescription Drug
• Proprietary Name: VERSACLOZ
• Generic Name: Clozapine
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2013-02-15
• Marketing End Date: 2019-05-31
• Marketing Category: NDA / NDA
• Application Number: NDA203479
• Labeler Name: Jazz Pharmaceuticals, Inc.
• Substance Name: CLOZAPINE
• Active Ingredient Strength: 50 mg/mL
• Pharm Classes: Atypical Antipsychotic [EPC]
• NDC Exclude Flag: N

Packaging

NDC 18860-121-01

1 BOTTLE in 1 BOX (18860-121-01) > 100 mL in 1 BOTTLE

• Marketing Start Date: 2013-02-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 18860-121-01 [18860012101]

VERSACLOZ SUSPENSION

• Marketing Category: NDA
• Application Number: NDA203479
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-02-15
• Marketing End Date: 2019-05-31

Drug Details

Active Ingredients

Ingredient	Strength
CLOZAPINE	50 mg/mL

OpenFDA Data

• SPL SET ID: 693cb9d4-39db-4ecf-9eae-b01f06f8d5d1
• Manufacturer:
  • Jazz Pharmaceuticals, Inc.
• UNII:
  • J60AR2IKIC
• RxNorm Concept Unique ID - RxCUI:
  • 1369825
  • 1369831

Pharmacological Class

• Atypical Antipsychotic [EPC]

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

NDC	Brand Name	Generic Name
18860-121	VERSACLOZ	VERSACLOZ
52817-601	VERSACLOZ	VERSACLOZ
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