Clofarabine

Product NDC
70121-1236
11-digit product format
701211236
Labeler code
70121
Product ID
70121-1236_9371cb36-5f01-4afa-bbd4-6886ae0fc277
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clofarabine
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA208857
Marketing category
ANDA
Marketing start
2017-11-06
Substance
CLOFARABINE
Active strength
1 mg/mL
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clofarabine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOFARABINE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii762RDY0Y2H
Rxcui486419

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
70121-1236-1Clofarabine20 mL in 1 VIAL, SINGLE-DOSEINJECTION205
70121-1236-1Clofarabine1 in 1 BOXINJECTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1236-1ML - Milliliter70121-12360dc7df1d-29e3-4b6b-b0e9-5f6541df2bda12017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1236CLOFARABINE INJECTION [AMNEAL PHARMACEUTICALS LLC]5Current NDC, Legacy NDC, 2 package rows20231224_0a273a2d-a1ff-412a-925e-696648730dae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
486419clofarabine 20 MG in 20 ML InjectionPSN0a273a2d-a1ff-412a-925e-696648730dae5
48641920 ML clofarabine 1 MG/ML InjectionSCD0a273a2d-a1ff-412a-925e-696648730dae5
486419clofarabine 20 MG per 20 ML InjectionSY0a273a2d-a1ff-412a-925e-696648730dae5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70121-1236-1701211236011 VIAL, SINGLE-DOSE in 1 BOX (70121-1236-1) / 20 mL in 1 VIAL, SINGLE-DOSE2017-11-060000-00-00NoNoCurrent