NDC 67457-450

Cladribine

Cladribine

Cladribine is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Cladribine.

• Product ID: 67457-450_24f4c9b6-3f6b-43cd-8604-7d5e5f61f8cf
• NDC: 67457-450
• Product Type: Human Prescription Drug
• Proprietary Name: Cladribine
• Generic Name: Cladribine
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2011-07-10
• Marketing End Date: 2022-12-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA200510
• Labeler Name: Mylan Institutional LLC
• Substance Name: CLADRIBINE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Purine Antimetabolite [EPC]
• NDC Exclude Flag: N

Packaging

NDC 67457-450-10

1 VIAL in 1 CARTON (67457-450-10) > 10 mL in 1 VIAL

• Marketing Start Date: 2014-06-18
• Marketing End Date: 2022-12-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67457-450-10 [67457045010]

Cladribine INJECTION

• Marketing Category: ANDA
• Application Number: ANDA200510
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-06-18

Drug Details

Active Ingredients

Ingredient	Strength
CLADRIBINE	1 mg/mL

OpenFDA Data

• SPL SET ID: bd1f701e-b64f-4347-a466-17c601f26b93
• Manufacturer:
  • Mylan Institutional LLC
• UNII:
  • 47M74X9YT5
• RxNorm Concept Unique ID - RxCUI:
  • 240754

Pharmacological Class

• Purine Antimetabolite [EPC]
• 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