DOXOrubicin Hydrochloride

Product NDC
62756-827
11-digit product format
627560827
Labeler code
62756
Product ID
62756-827_d95f19dc-a686-42c7-88dc-997659b803df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXOrubicin Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA091418
Marketing category
ANDA
Marketing start
2012-02-20
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
Rxcui1191138, 1790100

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
62756-827-40DOXOrubicin Hydrochloride100 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1005
62756-827-40DOXOrubicin Hydrochloride1 in 1 BOXINJECTION, SOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-827-40ML - Milliliter62756-8270dcd36c6-9975-4cfe-9497-1cab52c26b6a12013-04-01

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-827DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]5Current NDC, Legacy NDC, 2 package rows20220118_6bcde92b-e584-4919-866a-68847ea201ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191138DOXOrubicin HCl 2 MG/ML Injectable SolutionPSN6bcde92b-e584-4919-866a-68847ea201ba5
1790100DOXOrubicin HCl 50 MG in 25 ML InjectionPSN6bcde92b-e584-4919-866a-68847ea201ba5
179010025 ML doxorubicin hydrochloride 2 MG/ML InjectionSCD6bcde92b-e584-4919-866a-68847ea201ba5
1191138doxorubicin hydrochloride 2 MG/ML Injectable SolutionSCD6bcde92b-e584-4919-866a-68847ea201ba5
1790100doxorubicin hydrochloride 50 MG per 25 ML InjectionSY6bcde92b-e584-4919-866a-68847ea201ba5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62756-827-40627560827401 VIAL, MULTI-DOSE in 1 BOX (62756-827-40) / 100 mL in 1 VIAL, MULTI-DOSE2012-02-200000-00-00NoNoCurrent