FDA.reportPublic FDA data

DOXORUBICIN HYDROCHLORIDE

Product NDC
70710-1531
11-digit product format
707101531
Labeler code
70710
Product ID
70710-1531_de4d3f9e-b1f9-4f33-a163-cd36aeb7bc70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxorubicin hydrochloride
Dosage form
INJECTABLE, LIPOSOMAL
Route
INTRAVENOUS
Labeler
Zydus Pharmaceuticals USA Inc.
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DOXORUBICIN HYDROCHLORIDE
Listing expiration
2027-12-31

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
70710-1531-1DOXORUBICIN HYDROCHLORIDE1 in 1 CARTONINJECTABLE, LIPOSOMAL15
70710-1531-1DOXORUBICIN HYDROCHLORIDE25 mL in 1 VIAL, SINGLE-DOSEINJECTABLE, LIPOSOMAL255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1531DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [ZYDUS PHARMACEUTICALS USA INC.]4Current NDC, Legacy NDC, 2 package rows20240809_15a84bd6-b565-4722-bb92-e4c919620a90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790115DOXOrubicin HCl liposome 20 MG in 10 ML InjectionPSN15a84bd6-b565-4722-bb92-e4c919620a905
1790127DOXOrubicin HCl liposome 50 MG in 25 ML InjectionPSN15a84bd6-b565-4722-bb92-e4c919620a905
179011510 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCD15a84bd6-b565-4722-bb92-e4c919620a905
179012725 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCD15a84bd6-b565-4722-bb92-e4c919620a905
1790115doxorubicin hydrochloride liposome 20 MG per 10 ML InjectionSY15a84bd6-b565-4722-bb92-e4c919620a905
1790127doxorubicin hydrochloride liposome 50 MG per 25 ML InjectionSY15a84bd6-b565-4722-bb92-e4c919620a905

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70710-1531-1707101531011 VIAL, SINGLE-DOSE in 1 CARTON (70710-1531-1) / 25 mL in 1 VIAL, SINGLE-DOSE2020-09-140000-00-00NoNoCurrent