NDC 63323-140

Cladribine

Cladribine

Cladribine is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Cladribine.

• Product ID: 63323-140_9b00e23f-d8e3-87f7-e053-2995a90a038f
• NDC: 63323-140
• Product Type: Human Prescription Drug
• Proprietary Name: Cladribine
• Generic Name: Cladribine
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2004-12-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076571
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: CLADRIBINE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Purine Antimetabolite [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 63323-140-10

1 VIAL, SINGLE-DOSE in 1 CARTON (63323-140-10) > 10 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2004-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-140-10 [63323014010]

Cladribine INJECTION

• Marketing Category: ANDA
• Application Number: ANDA076571
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2004-12-01

Drug Details

Active Ingredients

Ingredient	Strength
CLADRIBINE	1 mg/mL

OpenFDA Data

• SPL SET ID: a2592a9b-bca6-4a5a-89c2-855a0634d5fe
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • 47M74X9YT5
• RxNorm Concept Unique ID - RxCUI:
  • 240754
• UPC Code:
  • 0363323140106

Pharmacological Class

• Purine Antimetabolite [EPC]

NDC Crossover Matching brand name "Cladribine" or generic name "Cladribine"

NDC	Brand Name	Generic Name
0143-9871	Cladribine	Cladribine
42658-010	Cladribine	Cladribine
63323-140	Cladribine	CLADRIBINE
67457-450	Cladribine	Cladribine
44087-4000	Mavenclad	Cladribine