FDA.reportPublic FDA data

Cytarabine

Product NDC
71288-108
11-digit product format
712880108
Labeler code
71288
Product ID
71288-108_ba035466-3b01-4e2b-abf5-d876619a2674
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cytarabine
Dosage form
INJECTION, SOLUTION
Route
INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA206189
Marketing category
ANDA
Marketing start
2020-06-26
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
71288-108-05Cytarabine5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION55
71288-108-06Cytarabine5 in 1 CARTONINJECTION, SOLUTION55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-108CYTARABINE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20220115_446f6765-5375-6368-4755-4944574f5721.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731355cytarabine 100 MG in 5 ML InjectionPSN446f6765-5375-6368-4755-4944574f57215
17313555 ML cytarabine 20 MG/ML InjectionSCD446f6765-5375-6368-4755-4944574f57215
17313555 ML ara-C 20 MG/ML InjectionSY446f6765-5375-6368-4755-4944574f57215
1731355cytarabine 100 MG per 5 ML InjectionSY446f6765-5375-6368-4755-4944574f57215

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-108-05712880108055 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
71288-108-06712880108065 VIAL, SINGLE-DOSE in 1 CARTON (71288-108-06) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-108-05) 2020-06-260000-00-00NoNoCurrent