NDC 52817-601

VERSACLOZ

Clozapine

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

• Product ID: 52817-601_67133614-3515-4b84-942e-6d1e00281027
• NDC: 52817-601
• Product Type: Human Prescription Drug
• Proprietary Name: VERSACLOZ
• Generic Name: Clozapine
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2018-06-15
• Marketing Category: NDA / NDA
• Application Number: NDA203479
• Labeler Name: TruPharma, LLC
• Substance Name: CLOZAPINE
• Active Ingredient Strength: 50 mg/mL
• Pharm Classes: Atypical Antipsychotic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 52817-601-38

1 BOTTLE in 1 BOX (52817-601-38) > 100 mL in 1 BOTTLE

• Marketing Start Date: 2018-06-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52817-601-38 [52817060138]

VERSACLOZ SUSPENSION

• Marketing Category: NDA
• Application Number: NDA203479
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-06-15

Drug Details

Active Ingredients

Ingredient	Strength
CLOZAPINE	50 mg/mL

OpenFDA Data

• SPL SET ID: 2592c9a8-fd74-4e0d-a895-b07b014cf355
• Manufacturer:
  • TruPharma, LLC
• 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