Fludarabine phosphate

Product NDC
45963-621
11-digit product format
459630621
Labeler code
45963
Product ID
45963-621_e0dcd67d-bac1-44b3-ab5f-5c539c00afea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fludarabine phosphate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Actavis Pharma, Inc.
Application
ANDA203738
Marketing category
ANDA
Marketing start
2017-03-02
Marketing end
0000-00-00
Substance
FLUDARABINE PHOSPHATE
Active strength
25 mg/mL
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45963-621-51ML - Milliliter45963-621ddc868cd-0bf0-4eee-84dd-b93c702e40d112017-04-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45963-621-51459630621511 VIAL, SINGLE-DOSE in 1 CARTON (45963-621-51) > 2 mL in 1 VIAL, SINGLE-DOSE2017-03-020000-00-00NoNoCurrent