Doxorubicin Hydrochloride

Product NDC
0069-4004
11-digit product format
000694004
Labeler code
0069
Product ID
0069-4004_7de0221b-3903-4ec6-a5ba-9ede8e8a45a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxorubicin Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA050629
Marketing category
NDA
Marketing start
2013-03-17
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
2021-12-31
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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-4004-05Doxorubicin Hydrochloride5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION514
0069-4004-05Doxorubicin Hydrochloride1 in 1 CARTONINJECTION, SOLUTION114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-4004DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]13Legacy NDC, 2 package rows20241113_00634b2b-4e48-4178-8877-28582af894ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790097DOXOrubicin HCl 10 MG in 5 mL InjectionPSN00634b2b-4e48-4178-8877-28582af894ad14
1191138DOXOrubicin HCl 2 MG/ML Injectable SolutionPSN00634b2b-4e48-4178-8877-28582af894ad14
1790099DOXOrubicin HCl 20 MG in 10 ML InjectionPSN00634b2b-4e48-4178-8877-28582af894ad14
1790100DOXOrubicin HCl 50 MG in 25 ML InjectionPSN00634b2b-4e48-4178-8877-28582af894ad14
179009910 ML doxorubicin hydrochloride 2 MG/ML InjectionSCD00634b2b-4e48-4178-8877-28582af894ad14
179010025 ML doxorubicin hydrochloride 2 MG/ML InjectionSCD00634b2b-4e48-4178-8877-28582af894ad14
17900975 ML doxorubicin hydrochloride 2 MG/ML InjectionSCD00634b2b-4e48-4178-8877-28582af894ad14
1191138doxorubicin hydrochloride 2 MG/ML Injectable SolutionSCD00634b2b-4e48-4178-8877-28582af894ad14
1790097doxorubicin hydrochloride 10 MG per 5 ML InjectionSY00634b2b-4e48-4178-8877-28582af894ad14
1790099doxorubicin hydrochloride 20 MG per 10 ML InjectionSY00634b2b-4e48-4178-8877-28582af894ad14
1790100doxorubicin hydrochloride 50 MG per 25 ML InjectionSY00634b2b-4e48-4178-8877-28582af894ad14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0069-4004-05000694004051 VIAL, SINGLE-DOSE in 1 CARTON (0069-4004-05) > 5 mL in 1 VIAL, SINGLE-DOSE2013-03-170000-00-00NoNoCurrent