clofarabine

Product NDC
67457-546
11-digit product format
674570546
Labeler code
67457
Product ID
67457-546_91ccea15-3700-4756-a4c6-e1121b95ef99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clofarabine
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA208860
Marketing category
ANDA
Marketing start
2017-11-06
Marketing end
2026-05-31
Substance
CLOFARABINE
Active strength
1 mg/mL
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag
No
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
539f51b2-42f0-18ba-d69a-4dc0951237b7Product name720250107
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
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
67457-546-20clofarabine20 mL in 1 VIAL, SINGLE-DOSEINJECTION205
67457-546-20clofarabine1 in 1 CARTONINJECTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-546-20ML - Milliliter67457-54671faefd9-50ac-406d-b670-e6bcf37ed95412017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-546CLOFARABINE INJECTION [MYLAN INSTITUTIONAL LLC]5Current NDC, Legacy NDC, 2 package rows20250104_1f8ac128-c25d-41f4-9f90-410a792acd66.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67457-546-20674570546201 VIAL, SINGLE-DOSE in 1 CARTON (67457-546-20) / 20 mL in 1 VIAL, SINGLE-DOSE2017-11-062026-05-31NoNoCurrent