FDA.reportPublic FDA data

RYTELO

Product NDC
82959-112
11-digit product format
829590112
Labeler code
82959
Product ID
82959-112_b96b0022-c4f5-458e-aa7e-21c62ac5cd8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
imetelstat sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Geron Corporation
Application
NDA217779
Marketing category
NDA
Marketing start
2024-06-06
Substance
IMETELSTAT SODIUM
Active strength
47 mg/1
Pharmacologic classes
Oligonucleotide Telomerase Inhibitor [EPC], Oligonucleotide Telomerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RYTELO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IMETELSTAT SODIUM47 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2AW48LAZ4I
Rxcui2685241, 2685246, 2685248, 2685250

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
93d8cf53-1a5b-416b-990f-9616b00253fcProduct name120250224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82959-112-01RYTELO1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,14
82959-112-01RYTELO1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82959-112-01EA - Each82959-112d8a235af-2a86-4972-89f8-b5ba9ec9b7a412024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82959-112RYTELO (IMETELSTAT SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GERON CORPORATION]2Current NDC, 2 package rows20240618_b0fab7ca-e578-43c5-9df6-bdaff4182257.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2685248imetelstat 188 MG InjectionPSNb0fab7ca-e578-43c5-9df6-bdaff41822574
2685241imetelstat 47 MG InjectionPSNb0fab7ca-e578-43c5-9df6-bdaff41822574
2685250RYTELO 188 MG InjectionPSNb0fab7ca-e578-43c5-9df6-bdaff41822574
2685246RYTELO 47 MG InjectionPSNb0fab7ca-e578-43c5-9df6-bdaff41822574
2685250imetelstat 188 MG Injection [Rytelo]SBDb0fab7ca-e578-43c5-9df6-bdaff41822574
2685246imetelstat 47 MG Injection [Rytelo]SBDb0fab7ca-e578-43c5-9df6-bdaff41822574
2685248imetelstat 188 MG InjectionSCDb0fab7ca-e578-43c5-9df6-bdaff41822574
2685241imetelstat 47 MG InjectionSCDb0fab7ca-e578-43c5-9df6-bdaff41822574
2685248imetelstat 188 MG (equivalent to imetelstat sodium 200 MG) InjectionSYb0fab7ca-e578-43c5-9df6-bdaff41822574
2685241imetelstat 47 MG (equivalent to imetelstat sodium 50 MG) InjectionSYb0fab7ca-e578-43c5-9df6-bdaff41822574
2685250Rytelo 188 MG InjectionSYb0fab7ca-e578-43c5-9df6-bdaff41822574
2685246Rytelo 47 MG InjectionSYb0fab7ca-e578-43c5-9df6-bdaff41822574

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82959-112-01829590112011 VIAL, SINGLE-DOSE in 1 CARTON (82959-112-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2024-06-06NoNoHistorical