Home NDC 82959-111 RYTELO
Product NDC 82959-111
11-digit product format 829590111
Labeler code 82959
Product ID 82959-111_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 188 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217779-001 RYTELO IMETELSTAT SODIUM EQ 47MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 N217779-002 RYTELO IMETELSTAT SODIUM EQ 188MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217779-001 9388415 2026-09-09 U-3956 2024-07-03 N217779-001 9388416 2026-09-09 U-3956 2024-07-03 N217779-001 7494982 2026-12-27 Drug substance, Drug product 2024-07-03 N217779-001 12442000 2033-03-15 U-3956 2025-11-03 N217779-001 9375485 2033-03-15 U-3956 2024-07-03 N217779-001 12171778 2039-06-16 U-3956 2025-01-15 N217779-002 9388415 2026-09-09 U-3956 2024-07-03 N217779-002 9388416 2026-09-09 U-3956 2024-07-03 N217779-002 7494982 2026-12-27 Drug substance, Drug product 2024-07-03 N217779-002 12442000 2033-03-15 U-3956 2025-11-03 N217779-002 9375485 2033-03-15 U-3956 2024-07-03 N217779-002 12171778 2039-06-16 U-3956 2025-01-15
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217779-001 ODE-482 2031-06-06 N217779-002 ODE-482 2031-06-06
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N217779-001 RYTELO EQ 47MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217779-002 RYTELO EQ 188MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217779-001 RYTELO EQ 47MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217779-002 RYTELO EQ 188MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217779-001 RYTELO EQ 47MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217779-002 RYTELO EQ 188MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217779-001 RYTELO EQ 47MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217779-002 RYTELO EQ 188MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217779-001 RYTELO EQ 47MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217779-002 RYTELO EQ 188MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217779-001 RYTELO EQ 47MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217779-002 RYTELO EQ 188MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217779-001 RYTELO EQ 47MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217779-002 RYTELO EQ 188MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217779-001 RYTELO EQ 47MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217779-002 RYTELO EQ 188MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217779-001 RYTELO EQ 47MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217779-002 RYTELO EQ 188MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217779-001 RYTELO EQ 47MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217779-002 RYTELO EQ 188MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217779-001 RYTELO EQ 47MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217779-002 RYTELO EQ 188MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217779-001 RYTELO EQ 47MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217779-002 RYTELO EQ 188MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217779-001 RYTELO EQ 47MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217779-002 RYTELO EQ 188MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217779-001 RYTELO EQ 47MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217779-002 RYTELO EQ 188MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 301d65b070ca…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217779-001 RYTELO EQ 47MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217779-002 RYTELO EQ 188MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-06-06 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 142 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N217779-001 9388415 2026-09-09 U-3956 2024-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217779-001 9388416 2026-09-09 U-3956 2024-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217779-001 7494982 2026-12-27 Drug substance, Drug product 2024-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217779-001 12442000 2033-03-15 U-3956 2025-11-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217779-001 9375485 2033-03-15 U-3956 2024-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217779-001 12171778 2039-06-16 U-3956 2025-01-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217779-002 9388415 2026-09-09 U-3956 2024-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217779-002 9388416 2026-09-09 U-3956 2024-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217779-002 7494982 2026-12-27 Drug substance, Drug product 2024-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217779-002 12442000 2033-03-15 U-3956 2025-11-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217779-002 9375485 2033-03-15 U-3956 2024-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217779-002 12171778 2039-06-16 U-3956 2025-01-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217779-001 9388415 2026-09-09 U-3956 2024-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217779-001 9388416 2026-09-09 U-3956 2024-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217779-001 7494982 2026-12-27 Drug substance, Drug product 2024-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217779-001 12442000 2033-03-15 U-3956 2025-11-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217779-001 9375485 2033-03-15 U-3956 2024-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217779-001 12171778 2039-06-16 U-3956 2025-01-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217779-002 9388415 2026-09-09 U-3956 2024-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217779-002 9388416 2026-09-09 U-3956 2024-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217779-002 7494982 2026-12-27 Drug substance, Drug product 2024-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217779-002 12442000 2033-03-15 U-3956 2025-11-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217779-002 9375485 2033-03-15 U-3956 2024-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217779-002 12171778 2039-06-16 U-3956 2025-01-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217779-001 9388415 2026-09-09 U-3956 2024-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217779-001 9388416 2026-09-09 U-3956 2024-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217779-001 7494982 2026-12-27 Drug substance, Drug product 2024-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217779-001 12442000 2033-03-15 U-3956 2025-11-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217779-001 9375485 2033-03-15 U-3956 2024-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217779-001 12171778 2039-06-16 U-3956 2025-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217779-002 9388415 2026-09-09 U-3956 2024-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217779-002 9388416 2026-09-09 U-3956 2024-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217779-002 7494982 2026-12-27 Drug substance, Drug product 2024-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217779-002 12442000 2033-03-15 U-3956 2025-11-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217779-002 9375485 2033-03-15 U-3956 2024-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217779-002 12171778 2039-06-16 U-3956 2025-01-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217779-001 7494982 2025-12-27 Drug substance, Drug product 2024-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217779-001 9388415 2026-09-09 U-3956 2024-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217779-001 9388416 2026-09-09 U-3956 2024-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217779-001 12442000 2033-03-15 U-3956 2025-11-03 31067a03dcf5…
Observed Orange Book exclusivity history# 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 Ingredient Strength IMETELSTAT SODIUM 188 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2AW48LAZ4I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2685241 Internal RxNorm lookup 2685246 Internal RxNorm lookup 2685248 Internal RxNorm lookup 2685250 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82959-111-01 RYTELO 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 4 82959-111-01 RYTELO 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82959-111 RYTELO (IMETELSTAT SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GERON CORPORATION] 2 Current NDC, 2 package rows 20240618_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82959-111-01 82959011101 1 VIAL, SINGLE-DOSE in 1 CARTON (82959-111-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2024-06-06 No No Current