Dexrazoxane

Product NDC
51991-942
11-digit product format
519910942
Labeler code
51991
Product ID
51991-942_3cf93d43-a779-4d9a-9ef5-1648e6ffa278
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexrazoxane Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA207321
Marketing category
ANDA
Marketing start
2016-12-05
Marketing end
0000-00-00
Substance
DEXRAZOXANE HYDROCHLORIDE
Active strength
500 mg/50mL
Pharmacologic classes
Cytoprotective Agent [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-942-98EA - Each51991-9426de6336e-d5c5-4b15-b27f-cca4b2f2111e12017-10-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51991-942-98519910942981 VIAL, SINGLE-DOSE in 1 CARTON (51991-942-98) > 50 mL in 1 VIAL, SINGLE-DOSE2017-06-260000-00-00NoNoCurrent