FDA.reportPublic FDA data

Adriamycin

Product NDC
0143-9547
11-digit product format
001439547
Labeler code
0143
Product ID
0143-9547_7eb88b4b-34e3-4d47-80f4-f17bd690d3b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxorubicin Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA062975
Marketing category
ANDA
Marketing start
1996-05-01
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
750deab0-bb49-36cc-d493-bfaec857a32eProduct name520190807
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0143-9547-012026-01-29C16284748780-149896155-a1b3-586f-e063-e6dba90add90These highlights do not include all the information needed to use ADRIAMYCIN (DOXOrubicin HCl) safely and effectively. See full prescribing information for ADRIAMYCIN ( Doxorubicin HCl) . ADRIAMYCIN (DOXOrubicin HCl) Injection, USP, for intravenous use Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9547-01Adriamycin25 mL in 1 VIALINJECTION, SOLUTION2510
0143-9547-01Adriamycin1 in 1 BOXINJECTION, SOLUTION110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9547-01ML - Milliliter0143-95476f0bdfe3-92f2-4553-9d18-147b1ce9264d12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9547ADRIAMYCIN (DOXORUBICIN HYDROCHLORIDE) INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]10Legacy NDC, 2 package rows20240413_0f153c1e-efce-4276-8273-d9e4c8455d16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1799305ADRIAMYCIN 10 MG in 5 ML InjectionPSN0f153c1e-efce-4276-8273-d9e4c8455d1610
1799310ADRIAMYCIN 2 MG/ML Injectable SolutionPSN0f153c1e-efce-4276-8273-d9e4c8455d1610
1799308ADRIAMYCIN 20 MG in 10 ML InjectionPSN0f153c1e-efce-4276-8273-d9e4c8455d1610
1799307ADRIAMYCIN 50 MG in 25 ML InjectionPSN0f153c1e-efce-4276-8273-d9e4c8455d1610
1790097DOXOrubicin HCl 10 MG in 5 mL InjectionPSN0f153c1e-efce-4276-8273-d9e4c8455d1610
1191138DOXOrubicin HCl 2 MG/ML Injectable SolutionPSN0f153c1e-efce-4276-8273-d9e4c8455d1610
1790099DOXOrubicin HCl 20 MG in 10 ML InjectionPSN0f153c1e-efce-4276-8273-d9e4c8455d1610
1790100DOXOrubicin HCl 50 MG in 25 ML InjectionPSN0f153c1e-efce-4276-8273-d9e4c8455d1610
179930810 ML doxorubicin hydrochloride 2 MG/ML Injection [Adriamycin]SBD0f153c1e-efce-4276-8273-d9e4c8455d1610
179930725 ML doxorubicin hydrochloride 2 MG/ML Injection [Adriamycin]SBD0f153c1e-efce-4276-8273-d9e4c8455d1610
17993055 ML doxorubicin hydrochloride 2 MG/ML Injection [Adriamycin]SBD0f153c1e-efce-4276-8273-d9e4c8455d1610
1799310doxorubicin hydrochloride 2 MG/ML Injectable Solution [Adriamycin]SBD0f153c1e-efce-4276-8273-d9e4c8455d1610
179009910 ML doxorubicin hydrochloride 2 MG/ML InjectionSCD0f153c1e-efce-4276-8273-d9e4c8455d1610
179010025 ML doxorubicin hydrochloride 2 MG/ML InjectionSCD0f153c1e-efce-4276-8273-d9e4c8455d1610
17900975 ML doxorubicin hydrochloride 2 MG/ML InjectionSCD0f153c1e-efce-4276-8273-d9e4c8455d1610
1191138doxorubicin hydrochloride 2 MG/ML Injectable SolutionSCD0f153c1e-efce-4276-8273-d9e4c8455d1610
17993055 ML Adriamycin 2 MG/ML InjectionSY0f153c1e-efce-4276-8273-d9e4c8455d1610
1799310Adriamycin 2 MG/ML Injectable SolutionSY0f153c1e-efce-4276-8273-d9e4c8455d1610
1799308ADRIAMYCIN 20 MG per 10 ML InjectionSY0f153c1e-efce-4276-8273-d9e4c8455d1610
1799307ADRIAMYCIN 50 MG per 25 ML InjectionSY0f153c1e-efce-4276-8273-d9e4c8455d1610
1790097doxorubicin hydrochloride 10 MG per 5 ML InjectionSY0f153c1e-efce-4276-8273-d9e4c8455d1610
1790099doxorubicin hydrochloride 20 MG per 10 ML InjectionSY0f153c1e-efce-4276-8273-d9e4c8455d1610
1790100doxorubicin hydrochloride 50 MG per 25 ML InjectionSY0f153c1e-efce-4276-8273-d9e4c8455d1610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9547-01001439547011 VIAL in 1 BOX (0143-9547-01) > 25 mL in 1 VIAL1 vial1996-05-010000-00-00NoNoCurrent