Doxorubicin Hydrochloride

Product NDC
43598-682
11-digit product format
435980682
Labeler code
43598
Product ID
43598-682_ffeb761a-aab9-be2c-c0d6-efd6421dfeb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxorubicin Hydrochloride
Dosage form
INJECTABLE, LIPOSOMAL
Route
INTRAVENOUS
Labeler
Dr. Reddy's Laboratories Inc
Application
ANDA208657
Marketing category
ANDA
Marketing start
2018-03-13
Marketing end
0000-00-00
Substance
DOXORUBICIN HYDROCHLORIDE
Active strength
2 mg/mL
Pharmacologic classes
Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-682-35ML - Milliliter43598-682dfd1e87e-669a-4836-88e9-d2f7a55b493512018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-682DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [DR. REDDY'S LABORATORIES INC]5Legacy NDC20230411_8216352e-dbf6-b1b0-3ae6-614ed44ef55e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-682-35435980682351 VIAL, SINGLE-DOSE in 1 PACKAGE (43598-682-35) > 10 mL in 1 VIAL, SINGLE-DOSE2018-03-130000-00-00NoNoCurrent