Doxorubicin Hydrochloride

Product NDC
70121-1219
11-digit product format
701211219
Labeler code
70121
Product ID
70121-1219_f4a01f55-65d7-401f-ac2f-e1511bf3a429
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxorubicin Hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA208888
Marketing category
ANDA
Marketing start
2017-02-17
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, 1872062

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
70121-1219-1Doxorubicin Hydrochloride25 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,2512
70121-1219-1Doxorubicin Hydrochloride1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1219DOXORUBICIN HYDROCHLORIDE (DOXORUBICIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION DOXORUBICIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC]12Current NDC, Legacy NDC, 2 package rows20240830_d928625e-c1ef-4f25-8d25-764c8c6aab67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1872062DOXOrubicin HCl 20 MG InjectionPSNd928625e-c1ef-4f25-8d25-764c8c6aab6712
1790095DOXOrubicin HCl 50 MG InjectionPSNd928625e-c1ef-4f25-8d25-764c8c6aab6712
1872062doxorubicin hydrochloride 20 MG InjectionSCDd928625e-c1ef-4f25-8d25-764c8c6aab6712
1790095doxorubicin hydrochloride 50 MG InjectionSCDd928625e-c1ef-4f25-8d25-764c8c6aab6712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1219-1701211219011 VIAL in 1 CARTON (70121-1219-1) / 25 mL in 1 VIAL1 vial2017-02-170000-00-00NoNoCurrent