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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N217779-001RYTELOIMETELSTAT SODIUMEQ 47MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-06
N217779-002RYTELOIMETELSTAT SODIUMEQ 188MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-06

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217779-00193884152026-09-09U-39562024-07-03
N217779-00193884162026-09-09U-39562024-07-03
N217779-00174949822026-12-27Drug substance, Drug product2024-07-03
N217779-001124420002033-03-15U-39562025-11-03
N217779-00193754852033-03-15U-39562024-07-03
N217779-001121717782039-06-16U-39562025-01-15
N217779-00293884152026-09-09U-39562024-07-03
N217779-00293884162026-09-09U-39562024-07-03
N217779-00274949822026-12-27Drug substance, Drug product2024-07-03
N217779-002124420002033-03-15U-39562025-11-03
N217779-00293754852033-03-15U-39562024-07-03
N217779-002121717782039-06-16U-39562025-01-15

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N217779-001ODE-4822031-06-06
N217779-002ODE-4822031-06-06

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N217779-001RYTELOEQ 47MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-0684e616aacf4f…
2026-09-14 22:38:342026-08N217779-002RYTELOEQ 188MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-0684e616aacf4f…
2026-08-18 06:07:402026-07N217779-001RYTELOEQ 47MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-06caaa826d4ba7…
2026-08-18 06:07:402026-07N217779-002RYTELOEQ 188MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217779-001RYTELOEQ 47MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217779-002RYTELOEQ 188MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217779-001RYTELOEQ 47MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217779-002RYTELOEQ 188MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N217779-001RYTELOEQ 47MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217779-002RYTELOEQ 188MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217779-001RYTELOEQ 47MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217779-002RYTELOEQ 188MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217779-001RYTELOEQ 47MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217779-002RYTELOEQ 188MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217779-001RYTELOEQ 47MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217779-002RYTELOEQ 188MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217779-001RYTELOEQ 47MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217779-002RYTELOEQ 188MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217779-001RYTELOEQ 47MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217779-002RYTELOEQ 188MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217779-001RYTELOEQ 47MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217779-002RYTELOEQ 188MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217779-001RYTELOEQ 47MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-06d06236e962d9…
2024-10-29 15:01 UTC2024-10N217779-002RYTELOEQ 188MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217779-001RYTELOEQ 47MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217779-002RYTELOEQ 188MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217779-001RYTELOEQ 47MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217779-002RYTELOEQ 188MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-06301d65b070ca…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217779-001RYTELOEQ 47MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217779-002RYTELOEQ 188MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-06-06a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 4 · 142 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N217779-00193884152026-09-09U-39562024-07-0384e616aacf4f…
2026-09-14 22:38:342026-08N217779-00193884162026-09-09U-39562024-07-0384e616aacf4f…
2026-09-14 22:38:342026-08N217779-00174949822026-12-27Drug substance, Drug product2024-07-0384e616aacf4f…
2026-09-14 22:38:342026-08N217779-001124420002033-03-15U-39562025-11-0384e616aacf4f…
2026-09-14 22:38:342026-08N217779-00193754852033-03-15U-39562024-07-0384e616aacf4f…
2026-09-14 22:38:342026-08N217779-001121717782039-06-16U-39562025-01-1584e616aacf4f…
2026-09-14 22:38:342026-08N217779-00293884152026-09-09U-39562024-07-0384e616aacf4f…
2026-09-14 22:38:342026-08N217779-00293884162026-09-09U-39562024-07-0384e616aacf4f…
2026-09-14 22:38:342026-08N217779-00274949822026-12-27Drug substance, Drug product2024-07-0384e616aacf4f…
2026-09-14 22:38:342026-08N217779-002124420002033-03-15U-39562025-11-0384e616aacf4f…
2026-09-14 22:38:342026-08N217779-00293754852033-03-15U-39562024-07-0384e616aacf4f…
2026-09-14 22:38:342026-08N217779-002121717782039-06-16U-39562025-01-1584e616aacf4f…
2026-08-18 06:07:402026-07N217779-00193884152026-09-09U-39562024-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07N217779-00193884162026-09-09U-39562024-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07N217779-00174949822026-12-27Drug substance, Drug product2024-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07N217779-001124420002033-03-15U-39562025-11-03caaa826d4ba7…
2026-08-18 06:07:402026-07N217779-00193754852033-03-15U-39562024-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07N217779-001121717782039-06-16U-39562025-01-15caaa826d4ba7…
2026-08-18 06:07:402026-07N217779-00293884152026-09-09U-39562024-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07N217779-00293884162026-09-09U-39562024-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07N217779-00274949822026-12-27Drug substance, Drug product2024-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07N217779-002124420002033-03-15U-39562025-11-03caaa826d4ba7…
2026-08-18 06:07:402026-07N217779-00293754852033-03-15U-39562024-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07N217779-002121717782039-06-16U-39562025-01-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217779-00193884152026-09-09U-39562024-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217779-00193884162026-09-09U-39562024-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217779-00174949822026-12-27Drug substance, Drug product2024-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217779-001124420002033-03-15U-39562025-11-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217779-00193754852033-03-15U-39562024-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217779-001121717782039-06-16U-39562025-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217779-00293884152026-09-09U-39562024-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217779-00293884162026-09-09U-39562024-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217779-00274949822026-12-27Drug substance, Drug product2024-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217779-002124420002033-03-15U-39562025-11-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217779-00293754852033-03-15U-39562024-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217779-002121717782039-06-16U-39562025-01-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217779-00174949822025-12-27Drug substance, Drug product2024-07-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217779-00193884152026-09-09U-39562024-07-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217779-00193884162026-09-09U-39562024-07-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217779-001124420002033-03-15U-39562025-11-0331067a03dcf5…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N217779-001ODE-4822031-06-0684e616aacf4f…
2026-09-14 22:38:342026-08N217779-002ODE-4822031-06-0684e616aacf4f…
2026-08-18 06:07:402026-07N217779-001ODE-4822031-06-06caaa826d4ba7…
2026-08-18 06:07:402026-07N217779-002ODE-4822031-06-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217779-001ODE-4822031-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217779-002ODE-4822031-06-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217779-001ODE-4822031-06-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217779-002ODE-4822031-06-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N217779-001ODE-4822031-06-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217779-002ODE-4822031-06-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217779-001ODE-4822031-06-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217779-002ODE-4822031-06-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217779-001ODE-4822031-06-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217779-002ODE-4822031-06-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217779-001ODE-4822031-06-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217779-002ODE-4822031-06-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217779-001ODE-4822031-06-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217779-002ODE-4822031-06-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217779-001ODE-4822031-06-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217779-002ODE-4822031-06-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217779-001ODE-4822031-06-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217779-002ODE-4822031-06-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217779-001ODE-4822031-06-06d06236e962d9…
2024-10-29 15:01 UTC2024-10N217779-002ODE-4822031-06-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217779-001ODE-4822031-06-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217779-002ODE-4822031-06-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217779-001ODE-4822031-06-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217779-002ODE-4822031-06-06301d65b070ca…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217779-001ODE-4822031-06-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217779-002ODE-4822031-06-06a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2AW48LAZ4IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2685241Internal RxNorm lookup
2685246Internal RxNorm lookup
2685248Internal RxNorm lookup
2685250Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b0fab7ca-e578-43c5-9df6-bdaff4182257Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RYTELOIMETELSTAT SODIUMGeron Corporationb0fab7ca-e578-43c5-9df6-bdaff41822572026-04-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 217779
application number: NDA217779
ndc (product): 82959-112

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-DOSE2024-06-06NoNoCurrent