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 ID42658-010_9969eef5-5686-722d-e053-2995a90afffc
NDC42658-010
Product TypeHuman Prescription Drug
Proprietary NameCladribine
Generic NameCladribine
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA210856
Labeler NameHisun Pharmaceuticals USA, Inc.
Substance NameCLADRIBINE
Active Ingredient Strength1 mg/mL
Pharm ClassesPurine Antimetabolite [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42658-010-02

10 mL in 1 VIAL, SINGLE-DOSE (42658-010-02)
Marketing Start Date2020-04-01
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
CLADRIBINE1 mg/mL

Pharmacological Class

  • Purine Antimetabolite [EPC]

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

NDCBrand NameGeneric Name
63323-140CladribineCLADRIBINE
67457-450CladribineCladribine
0143-9871CladribineCladribine
42658-010CladribineCladribine
44087-4000MavencladCladribine

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.