FDA.reportPublic FDA data

Cytarabine

Product NDC
68083-343
11-digit product format
680830343
Labeler code
68083
Product ID
68083-343_47628a16-dba0-4e55-ac61-70fc4d94730a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cytarabine
Dosage form
INJECTION, SOLUTION
Route
INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS
Labeler
Gland Pharma Limited
Application
ANDA211937
Marketing category
ANDA
Marketing start
2019-12-23
Substance
CYTARABINE
Active strength
20 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
Cytarabine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYTARABINE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04079A1RDZ
Rxcui1731355

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04c28f2f-dbd2-41cf-afd8-2fe8b3fb2f93Product name220210115
6b50ac01-634d-431e-b6ec-67435668b5b5Product name120200605
9a73eb90-b58c-4fa3-9acb-c965ada7a226Product name120200605
699672ea-953a-2798-2891-e277960c6893Product name220180914
675b5a39-d8c3-40a3-b593-72d314eef224Product name120170829
21b54d6a-c9b4-eec7-5d08-a7e2c08084ebProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-343-01Cytarabine5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION54
68083-343-05Cytarabine5 in 1 CARTONINJECTION, SOLUTION54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-343CYTARABINE INJECTION, SOLUTION [GLAND PHARMA LIMITED]4Current NDC, Legacy NDC, 2 package rows20200715_7ab50348-ca78-46a5-aba6-c35b6b21fbfe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731355cytarabine 100 MG in 5 ML InjectionPSN7ab50348-ca78-46a5-aba6-c35b6b21fbfe4
17313555 ML cytarabine 20 MG/ML InjectionSCD7ab50348-ca78-46a5-aba6-c35b6b21fbfe4
17313555 ML ara-C 20 MG/ML InjectionSY7ab50348-ca78-46a5-aba6-c35b6b21fbfe4
1731355cytarabine 100 MG per 5 ML InjectionSY7ab50348-ca78-46a5-aba6-c35b6b21fbfe4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-343-01680830343015 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
68083-343-05680830343055 VIAL, SINGLE-DOSE in 1 CARTON (68083-343-05) / 5 mL in 1 VIAL, SINGLE-DOSE (68083-343-01) 2019-12-230000-00-00NoNoCurrent