NDC 42658-010

Cladribine

Cladribine

Cladribine is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hisun Pharmaceuticals Usa, Inc.. The primary component is Cladribine.

• Product ID: 42658-010_9969eef5-5686-722d-e053-2995a90afffc
• NDC: 42658-010
• Product Type: Human Prescription Drug
• Proprietary Name: Cladribine
• Generic Name: Cladribine
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2020-04-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA210856
• Labeler Name: Hisun Pharmaceuticals USA, Inc.
• 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 42658-010-01

1 mL in 1 VIAL, SINGLE-DOSE (42658-010-01)

• Marketing Start Date: 2020-05-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42658-010-01 [42658001001]

Cladribine INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA210856
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-05-18

NDC 42658-010-02 [42658001002]

Cladribine INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA210856
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-04-01
• Marketing End Date: 2020-04-10

Drug Details

Active Ingredients

Ingredient	Strength
CLADRIBINE	1 mg/mL

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