Doxorubicin Hydrochloride

Product NDC
0143-9089
11-digit product format
001439089
Labeler code
0143
Product ID
0143-9089_7c916380-3ae0-4a64-945d-7b0da46b9715
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxorubicin Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA062975
Marketing category
ANDA
Marketing start
1996-05-01
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
82F2G7BL4EDOXORUBICIN HYDROCHLORIDE25316-40-9DOXORUBICIN HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0143-9089-01001439089011 VIAL in 1 BOX (0143-9089-01) / 10 mL in 1 VIAL1 vial2019-10-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Doxorubicin HydrochlorideHikma Pharmaceuticals USA Inc.2024-01-16HUMAN PRESCRIPTION DRUG LABEL3