Doxorubicin Hydrochloride

Product NDC
0069-1442
11-digit product format
000691442
Labeler code
0069
Product ID
0069-1442_b4c94e1f-f7c7-4b4b-9fe2-111903c0d312
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
2024-10-14
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
0069-1442-04000691442041 VIAL, MULTI-DOSE in 1 CARTON (0069-1442-04) / 100 mL in 1 VIAL, MULTI-DOSE2024-10-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Doxorubicin HydrochloridePfizer Laboratories Div Pfizer Inc | Pfizer Inc2026-04-30HUMAN PRESCRIPTION DRUG LABEL14
Doxorubicin HydrochloridePfizer Laboratories Div Pfizer Inc | Pfizer Inc2023-05-04HUMAN PRESCRIPTION DRUG LABEL11