FDA.reportPublic FDA data

Cytarabine

Product NDC
71288-109
11-digit product format
712880109
Labeler code
71288
Product ID
71288-109_695b376b-3972-4aef-b003-f1fb6fcde5b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cytarabine
Dosage form
INJECTION, SOLUTION
Route
INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA205696
Marketing category
ANDA
Marketing start
2018-07-17
Substance
CYTARABINE
Active strength
2 g/20mL
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
CYTARABINE2 g/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04079A1RDZ
Rxcui249364

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
71288-109-20Cytarabine1 in 1 CARTONINJECTION, SOLUTION13
71288-109-20Cytarabine20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-109-20ML - Milliliter71288-109a70d9a53-aab8-441f-b7c1-54483fd0583412018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-109CYTARABINE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20240517_8105e590-fc7e-45b7-9604-c2d0d1be5eac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
249364cytarabine 2 GM in 20 ML InjectionPSN8105e590-fc7e-45b7-9604-c2d0d1be5eac3
24936420 ML cytarabine 100 MG/ML InjectionSCD8105e590-fc7e-45b7-9604-c2d0d1be5eac3
24936420 ML ara-C 100 MG/ML InjectionSY8105e590-fc7e-45b7-9604-c2d0d1be5eac3
249364cytarabine 2 GM per 20 ML InjectionSY8105e590-fc7e-45b7-9604-c2d0d1be5eac3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71288-109-20712880109201 VIAL, SINGLE-DOSE in 1 CARTON (71288-109-20) / 20 mL in 1 VIAL, SINGLE-DOSE2018-07-170000-00-00NoNoCurrent