FDA.reportPublic FDA data

DOXORUBICIN HYDROCHLORIDE

Product NDC
49315-009
11-digit product format
493150009
Labeler code
49315
Product ID
49315-009_2c0f5abf-ca66-445c-9a35-e39b2111911e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxorubicin hydrochloride
Dosage form
INJECTABLE, LIPOSOMAL
Route
INTRAVENOUS
Labeler
Zydus Lifesciences Limited
Application
ANDA212299
Marketing category
ANDA
Marketing start
2020-09-14
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
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
Rxcui1790115, 1790127

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ee64805-1a32-49b4-a119-9376fc9e6633Product name520250305
750deab0-bb49-36cc-d493-bfaec857a32eProduct name520190807
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49315-009-07DOXORUBICIN HYDROCHLORIDE25 mL in 1 VIAL, SINGLE-DOSEINJECTABLE, LIPOSOMAL252
49315-009-07DOXORUBICIN HYDROCHLORIDE1 in 1 CARTONINJECTABLE, LIPOSOMAL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49315-009DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [ZYDUS LIFESCIENCES LIMITED]2Current NDC, Legacy NDC, 2 package rows20221107_bad467d4-7e27-4eda-b4d3-854460f0adab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790115DOXOrubicin HCl liposome 20 MG in 10 ML InjectionPSNbad467d4-7e27-4eda-b4d3-854460f0adab2
1790127DOXOrubicin HCl liposome 50 MG in 25 ML InjectionPSNbad467d4-7e27-4eda-b4d3-854460f0adab2
179011510 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCDbad467d4-7e27-4eda-b4d3-854460f0adab2
179012725 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCDbad467d4-7e27-4eda-b4d3-854460f0adab2
1790115doxorubicin hydrochloride liposome 20 MG per 10 ML InjectionSYbad467d4-7e27-4eda-b4d3-854460f0adab2
1790127doxorubicin hydrochloride liposome 50 MG per 25 ML InjectionSYbad467d4-7e27-4eda-b4d3-854460f0adab2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49315-009-07493150009071 VIAL, SINGLE-DOSE in 1 CARTON (49315-009-07) / 25 mL in 1 VIAL, SINGLE-DOSE2020-09-140000-00-00NoNoCurrent