Adriamycin

Product NDC
0143-9275
11-digit product format
001439275
Labeler code
0143
Product ID
0143-9275_79560e42-fedf-48d0-b2f9-db8b1feacf0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxorubicin Hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA062921
Marketing category
ANDA
Marketing start
2018-01-19
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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
0143-9275-01Adriamycin5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,57
0143-9275-01Adriamycin1 in 1 BOXINJECTION, POWDER, LYOPHILIZED,17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9275-01EA - Each0143-92752f034010-991f-4958-88e7-5e3fd0dbb05c12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9275ADRIAMYCIN (DOXORUBICIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]7Legacy NDC, 2 package rows20240413_090bc1b1-3dc2-408d-94e6-48d2a3d4426c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001102ADRIAMYCIN 10 MG InjectionPSN090bc1b1-3dc2-408d-94e6-48d2a3d4426c7
2001100ADRIAMYCIN 50 MG InjectionPSN090bc1b1-3dc2-408d-94e6-48d2a3d4426c7
1790103DOXOrubicin HCl 10 MG InjectionPSN090bc1b1-3dc2-408d-94e6-48d2a3d4426c7
1790095DOXOrubicin HCl 50 MG InjectionPSN090bc1b1-3dc2-408d-94e6-48d2a3d4426c7
2001102doxorubicin hydrochloride 10 MG Injection [Adriamycin]SBD090bc1b1-3dc2-408d-94e6-48d2a3d4426c7
2001100doxorubicin hydrochloride 50 MG Injection [Adriamycin]SBD090bc1b1-3dc2-408d-94e6-48d2a3d4426c7
1790103doxorubicin hydrochloride 10 MG InjectionSCD090bc1b1-3dc2-408d-94e6-48d2a3d4426c7
1790095doxorubicin hydrochloride 50 MG InjectionSCD090bc1b1-3dc2-408d-94e6-48d2a3d4426c7
2001102Adriamycin 10 MG InjectionSY090bc1b1-3dc2-408d-94e6-48d2a3d4426c7
2001100Adriamycin 50 MG InjectionSY090bc1b1-3dc2-408d-94e6-48d2a3d4426c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9275-01001439275011 VIAL in 1 BOX (0143-9275-01) > 5 mL in 1 VIAL1 vial2018-01-190000-00-00NoNoCurrent