FDA.reportPublic FDA data

Cytarabine

Product NDC
61703-305
11-digit product format
617030305
Labeler code
61703
Product ID
61703-305_d8c6ffbd-a0d9-4094-a6ea-d94cb93c5c2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYTARABINE
Dosage form
INJECTION, SOLUTION
Route
INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS
Labeler
Hospira, Inc.
Application
ANDA071868
Marketing category
ANDA
Marketing start
1990-06-04
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
61703-305-38Cytarabine5 in 1 CARTONINJECTION, SOLUTION521
61703-305-58Cytarabine5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION521

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61703-305-38ML - Milliliter61703-305273294c7-c5f4-4499-bb54-d95b1452890e12012-07-24
61703-305-58ML - Milliliter61703-3057bcdd219-9afe-4684-b276-89568cd9373212019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYTARABINEACTIVE INGREDIENT04079A1RDZCYTARABINE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]12
CYTARABINEACTIVE MOIETY04079A1RDZCYTARABINE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]12
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCYTARABINE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]12
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCYTARABINE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]12
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICYTARABINE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]12
WATERINACTIVE INGREDIENT059QF0KO0RCYTARABINE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61703-305CYTARABINE INJECTION, SOLUTION [HOSPIRA, INC.]21Current NDC, Legacy NDC, 2 package rows20240805_bc2fa221-ea56-48b8-8304-42cd81b8463b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731355cytarabine 100 MG in 5 ML InjectionPSNbc2fa221-ea56-48b8-8304-42cd81b8463b21
17313555 ML cytarabine 20 MG/ML InjectionSCDbc2fa221-ea56-48b8-8304-42cd81b8463b21
17313555 ML ara-C 20 MG/ML InjectionSYbc2fa221-ea56-48b8-8304-42cd81b8463b21
1731355cytarabine 100 MG per 5 ML InjectionSYbc2fa221-ea56-48b8-8304-42cd81b8463b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61703-305-38617030305385 VIAL, SINGLE-DOSE in 1 CARTON (61703-305-38) / 5 mL in 1 VIAL, SINGLE-DOSE (61703-305-58) 1990-06-040000-00-00NoNoCurrent
61703-305-58617030305585 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical