FDA.reportPublic FDA data

nelarabine

Product NDC
81927-111
11-digit product format
819270111
Labeler code
81927
Product ID
81927-111_f21b358e-9f41-4dc3-858f-b55f9a8af715
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nelarabine
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Shorla Oncology Inc.
Application
ANDA214809
Marketing category
ANDA
Marketing start
2023-03-15
Substance
NELARABINE
Active strength
5 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
nelarabine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NELARABINE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii60158CV180
Rxcui603566, 2722411

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
68e3b4d6-92e5-2b85-ee38-af06171b640cProduct name620250331

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81927-111-012025-04-29C16284748780-12cef2736-9d9a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use NELARABINE INJECTION safely and effectively. See full prescribing information for NELARABINE INJECTION. NELARABINE injection, for intravenous use Initial U.S. Approval: 2005
81927-111-062025-04-29C16284748780-12cef2736-9d9a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use NELARABINE INJECTION safely and effectively. See full prescribing information for NELARABINE INJECTION. NELARABINE injection, for intravenous use Initial U.S. Approval: 2005
81927-111-012025-01-30C16284748780-12cef2736-9d9a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use NELARABINE INJECTION safely and effectively. See full prescribing information for NELARABINE INJECTION. NELARABINE injection, for intravenous use Initial U.S. Approval: 2005
81927-111-062025-01-30C16284748780-12cef2736-9d9a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use NELARABINE INJECTION safely and effectively. See full prescribing information for NELARABINE INJECTION. NELARABINE injection, for intravenous use Initial U.S. Approval: 2005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81927-111-01nelarabine50 mL in 1 VIAL, SINGLE-DOSEINJECTION506
81927-111-01nelarabine1 in 1 CARTONINJECTION16
81927-111-06nelarabine6 in 1 CARTONINJECTION66
81927-111-06nelarabine50 mL in 1 VIAL, SINGLE-DOSEINJECTION506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81927-111-01ML - Milliliter81927-11120d83d4b-121a-47a7-8849-2af2bfc8262f12023-04-07
81927-111-06ML - Milliliter81927-11130d65b67-7d05-4706-9046-0ff64416ce6a12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81927-111NELARABINE INJECTION [SHORLA ONCOLOGY INC.]3Current NDC, 4 package rows20250430_fc401b06-4e3b-413e-a854-3e031c433862.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603566nelarabine 250 MG in 50 ML InjectionPSNfc401b06-4e3b-413e-a854-3e031c4338626
2722411nelarabine 375 MG in 75 ML InjectionPSNfc401b06-4e3b-413e-a854-3e031c4338626
60356650 ML nelarabine 5 MG/ML InjectionSCDfc401b06-4e3b-413e-a854-3e031c4338626
272241175 ML nelarabine 5 MG/ML InjectionSCDfc401b06-4e3b-413e-a854-3e031c4338626
603566nelarabine 250 MG per 50 ML InjectionSYfc401b06-4e3b-413e-a854-3e031c4338626
2722411nelarabine 375 MG per 75 ML InjectionSYfc401b06-4e3b-413e-a854-3e031c4338626

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
81927-111-01819270111011 VIAL, SINGLE-DOSE in 1 CARTON (81927-111-01) / 50 mL in 1 VIAL, SINGLE-DOSE2023-03-15NoNoHistorical
81927-111-06819270111066 VIAL, SINGLE-DOSE in 1 CARTON (81927-111-06) / 50 mL in 1 VIAL, SINGLE-DOSE2023-03-15NoNoHistorical