Epirubicin Hydrochloride

Product NDC
0143-9202
11-digit product format
001439202
Labeler code
0143
Product ID
0143-9202_a854383a-1d91-456c-baae-2e4011faf1a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Epirubicin Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065289
Marketing category
ANDA
Marketing start
2007-08-07
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
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
0143-9202-01ML - Milliliter0143-92021dc29321-2b2a-4784-b141-f098949549d412018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9202EPIRUBICIN HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]6Legacy NDC20240724_a24ff5f2-0a9a-4222-9135-1d4094ddd2e0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9202-01001439202011 VIAL in 1 BOX (0143-9202-01) > 25 mL in 1 VIAL1 vial2007-08-070000-00-00NoNoCurrent