FDA.reportPublic FDA data

Doxorubicin Hydrochloride

Product NDC
47335-050
11-digit product format
473350050
Labeler code
47335
Product ID
47335-050_efff8fef-d079-4581-8027-646e57a23c62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxorubicin Hydrochloride
Dosage form
INJECTABLE, LIPOSOMAL
Route
INTRAVENOUS
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA203263
Marketing category
ANDA
Marketing start
2013-02-05
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
47335-050-40Doxorubicin Hydrochloride1 in 1 PACKAGEINJECTABLE, LIPOSOMAL124
47335-050-40Doxorubicin Hydrochloride25 mL in 1 VIAL, SINGLE-DOSEINJECTABLE, LIPOSOMAL2524

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-050-40ML - Milliliter47335-0508da6f101-d8d4-4dc4-95c3-c19d9070ef3b12013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXORUBICIN HYDROCHLORIDEACTIVE INGREDIENT82F2G7BL4EDOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [SUN PHARMA GLOBAL FZE]10
DOXORUBICINACTIVE MOIETY80168379AGDOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [SUN PHARMA GLOBAL FZE]10
AMMONIUM SULFATEINACTIVE INGREDIENTSU46BAM238DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [SUN PHARMA GLOBAL FZE]10
CHOLESTEROLINACTIVE INGREDIENT97C5T2UQ7JDOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [SUN PHARMA GLOBAL FZE]10
HISTIDINEINACTIVE INGREDIENT4QD397987EDOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [SUN PHARMA GLOBAL FZE]10
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [SUN PHARMA GLOBAL FZE]10
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4NDOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [SUN PHARMA GLOBAL FZE]10
N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE, SODIUM SALTINACTIVE INGREDIENT3L6NN8ZZKUDOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [SUN PHARMA GLOBAL FZE]10
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [SUN PHARMA GLOBAL FZE]10
SUCROSEINACTIVE INGREDIENTC151H8M554DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [SUN PHARMA GLOBAL FZE]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-050DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [SUN PHARMACEUTICAL INDUSTRIES, INC.]23Current NDC, Legacy NDC, 2 package rows20250411_fbc48fa5-0bfb-4957-b13c-a56bb7a13b56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790115DOXOrubicin HCl liposome 20 MG in 10 ML InjectionPSNfbc48fa5-0bfb-4957-b13c-a56bb7a13b5624
1790127DOXOrubicin HCl liposome 50 MG in 25 ML InjectionPSNfbc48fa5-0bfb-4957-b13c-a56bb7a13b5624
179011510 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCDfbc48fa5-0bfb-4957-b13c-a56bb7a13b5624
179012725 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCDfbc48fa5-0bfb-4957-b13c-a56bb7a13b5624
1790115doxorubicin hydrochloride liposome 20 MG per 10 ML InjectionSYfbc48fa5-0bfb-4957-b13c-a56bb7a13b5624
1790127doxorubicin hydrochloride liposome 50 MG per 25 ML InjectionSYfbc48fa5-0bfb-4957-b13c-a56bb7a13b5624

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-050-40473350050401 VIAL, SINGLE-DOSE in 1 PACKAGE (47335-050-40) / 25 mL in 1 VIAL, SINGLE-DOSE2013-02-050000-00-00NoNoCurrent