Totect

Product NDC
76310-110
11-digit product format
763100110
Labeler code
76310
Product ID
76310-110_c9f42df8-86a6-4394-95d0-23d3a94b73db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexrazoxane hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Clinigen Limited
Application
NDA022025
Marketing category
NDA
Marketing start
2020-01-01
Marketing end
2022-11-30
Substance
DEXRAZOXANE HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Cytoprotective Agent [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76310-110-01EA - Each76310-1101cd9d696-5787-4f82-91b7-afba8eb989f212020-09-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76310-110-01763100110011 VIAL, SINGLE-USE in 1 CARTON (76310-110-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE2020-01-012022-11-30NoNoCurrent