FDA.reportPublic FDA data

Doxorubicin Hydrochloride

Product NDC
0143-9093
11-digit product format
001439093
Labeler code
0143
Product ID
0143-9093_3b0d5f19-5eab-4729-8fbf-3b988cbc6d04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxorubicin Hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA062921
Marketing category
ANDA
Marketing start
2018-01-19
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxorubicin Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXORUBICIN HYDROCHLORIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82F2G7BL4E
Rxcui1790095, 1790103

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ee64805-1a32-49b4-a119-9376fc9e6633Product name520250305
750deab0-bb49-36cc-d493-bfaec857a32eProduct name520190807

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9093-01Doxorubicin Hydrochloride25 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,253
0143-9093-01Doxorubicin Hydrochloride1 in 1 BOXINJECTION, POWDER, LYOPHILIZED,13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9093-01EA - Each0143-909352de5065-878b-429e-a991-83d811bf788612022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9093DOXORUBICIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]3Current NDC, Legacy NDC, 2 package rows20240427_f62aa88d-1e25-4049-87ec-99d42edd1d31.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790103DOXOrubicin HCl 10 MG InjectionPSNf62aa88d-1e25-4049-87ec-99d42edd1d313
1790095DOXOrubicin HCl 50 MG InjectionPSNf62aa88d-1e25-4049-87ec-99d42edd1d313
1790103doxorubicin hydrochloride 10 MG InjectionSCDf62aa88d-1e25-4049-87ec-99d42edd1d313
1790095doxorubicin hydrochloride 50 MG InjectionSCDf62aa88d-1e25-4049-87ec-99d42edd1d313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9093-01001439093011 VIAL in 1 BOX (0143-9093-01) / 25 mL in 1 VIAL1 vial2018-01-190000-00-00NoNoCurrent