cytarabine

Product NDC
25021-229
11-digit product format
250210229
Labeler code
25021
Product ID
25021-229_e9aed280-7c58-4817-b54d-ccbbdd4af575
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cytarabine
Dosage form
INJECTION, SOLUTION
Route
INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA211937
Marketing category
ANDA
Marketing start
2023-06-01
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
25021-229-05cytarabine5 mL in 1 VIALINJECTION, SOLUTION51
25021-229-05cytarabine5 in 1 CARTONINJECTION, SOLUTION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-229-05ML - Milliliter25021-2293968042d-4645-4f46-be1e-e8f1c1de588812023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-229CYTARABINE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 2 package rows20230607_90f5c7ab-9f15-487d-ba69-ee4107434bcc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731355cytarabine 100 MG in 5 ML InjectionPSN90f5c7ab-9f15-487d-ba69-ee4107434bcc1
17313555 ML cytarabine 20 MG/ML InjectionSCD90f5c7ab-9f15-487d-ba69-ee4107434bcc1
17313555 ML ara-C 20 MG/ML InjectionSY90f5c7ab-9f15-487d-ba69-ee4107434bcc1
1731355cytarabine 100 MG per 5 ML InjectionSY90f5c7ab-9f15-487d-ba69-ee4107434bcc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-229-05250210229055 VIAL in 1 CARTON (25021-229-05) / 5 mL in 1 VIAL5 vial2023-06-01NoNoHistorical