Doxorubicin Hydrochloride

Product NDC
0069-0358
11-digit product format
000690358
Labeler code
0069
Product ID
0069-0358_68af240b-3f2d-450c-b2bf-6f12d5176562
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxorubicin Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA050629
Marketing category
NDA
Marketing start
2024-08-19
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
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0069-0358-20000690358201 VIAL, SINGLE-DOSE in 1 CARTON (0069-0358-20) / 5 mL in 1 VIAL, SINGLE-DOSE2024-08-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Doxorubicin HydrochloridePfizer Laboratories Div Pfizer Inc2026-05-05HUMAN PRESCRIPTION DRUG LABEL28