EPIRUBICIN HYDROCHLORIDE

Product NDC
59923-701
11-digit product format
599230701
Labeler code
59923
Product ID
59923-701_b8e455c5-46b4-1827-e053-2a95a90ae2d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EPIRUBICIN HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Areva Pharmaceuticals,Inc.
Application
ANDA065361
Marketing category
ANDA
Marketing start
2014-05-19
Marketing end
0000-00-00
Substance
EPIRUBICIN HYDROCHLORIDE
Active strength
2 mg/mL
Pharmacologic classes
Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59923-701-00ML - Milliliter59923-701248f7981-da11-4fd3-829c-8e1cbb50cd8912013-07-02
59923-701-25ML - Milliliter59923-7018a92e371-436d-421d-bc69-56bc6f26c86612013-07-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59923-701EPIRUBICIN HYDROCHLORIDE INJECTION [AREVA PHARMACEUTICALS,INC.]9Legacy NDC20210115_ab115cc4-43cd-4a59-aa01-89e356ce3a08.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59923-701-00599230701001 VIAL in 1 CARTON (59923-701-00) > 100 mL in 1 VIAL1 vial2014-05-190000-00-00NoNoCurrent
59923-701-25599230701251 VIAL in 1 CARTON (59923-701-25) > 25 mL in 1 VIAL1 vial2014-05-190000-00-00NoNoCurrent