Exondys 51

Product NDC: 60923-284
11-digit product format: 609230284
Labeler code: 60923
Product ID: 60923-284_97565339-f295-43ab-98a9-bb6bdf2d049c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: eteplirsen
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Sarepta Therapeutics, Inc.
Application: NDA206488
Marketing category: NDA
Marketing start: 2016-09-19
Substance: ETEPLIRSEN
Active strength: 50 mg/mL
Pharmacologic classes: Antisense Oligonucleotide [EPC], Oligonucleotides, Antisense [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
N206488-001	EXONDYS 51	ETEPLIRSEN	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2016-09-19
N206488-002	EXONDYS 51	ETEPLIRSEN	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2016-09-19

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206488-001	RE48468	2028-10-27	U-2097		2021-04-12
N206488-001	RE47769	2029-02-02		Drug product	2019-12-18
N206488-001	10337003	2034-03-14	U-1918		2019-09-10
N206488-001	10364431	2034-03-14	U-1918		2019-08-28
N206488-001	10364431	2034-03-14	U-1919		2019-08-28
N206488-001	9506058	2034-03-14	U-1918		2016-12-01
N206488-001	9506058	2034-03-14	U-1919		2016-12-01
N206488-002	RE48468	2028-10-27	U-2097		2021-04-12
N206488-002	RE47769	2029-02-02		Drug product	2019-12-18
N206488-002	10337003	2034-03-14	U-1918		2019-09-10
N206488-002	10364431	2034-03-14	U-1918		2019-08-28
N206488-002	10364431	2034-03-14	U-1919		2019-08-28
N206488-002	9506058	2034-03-14	U-1918		2016-12-01
N206488-002	9506058	2034-03-14	U-1919		2016-12-01

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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`74a2ff9319b5…`

Observed Orange Book patent history#

Patent history page 1 of 30 · 1,188 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	N206488-001	RE48468	2028-10-27	U-2097		2021-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-001	RE47769	2029-02-02		Drug product	2019-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-001	10337003	2034-03-14	U-1918		2019-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-001	10364431	2034-03-14	U-1919		2019-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-001	10364431	2034-03-14	U-1918		2019-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-001	9506058	2034-03-14	U-1918		2016-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-001	9506058	2034-03-14	U-1919		2016-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-002	RE48468	2028-10-27	U-2097		2021-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-002	RE47769	2029-02-02		Drug product	2019-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-002	10337003	2034-03-14	U-1918		2019-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-002	10364431	2034-03-14	U-1919		2019-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-002	10364431	2034-03-14	U-1918		2019-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-002	9506058	2034-03-14	U-1918		2016-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-002	9506058	2034-03-14	U-1919		2016-12-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206488-001	RE48468	2028-10-27	U-2097		2021-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-001	RE47769	2029-02-02		Drug product	2019-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-001	10337003	2034-03-14	U-1918		2019-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-001	10364431	2034-03-14	U-1919		2019-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-001	10364431	2034-03-14	U-1918		2019-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-001	9506058	2034-03-14	U-1918		2016-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-001	9506058	2034-03-14	U-1919		2016-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-002	RE48468	2028-10-27	U-2097		2021-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-002	RE47769	2029-02-02		Drug product	2019-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-002	10337003	2034-03-14	U-1918		2019-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-002	10364431	2034-03-14	U-1919		2019-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-002	10364431	2034-03-14	U-1918		2019-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-002	9506058	2034-03-14	U-1918		2016-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-002	9506058	2034-03-14	U-1919		2016-12-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206488-001	RE48468	2028-10-27	U-2097		2021-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-001	RE47769	2029-02-02		Drug product	2019-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-001	10337003	2034-03-14	U-1918		2019-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-001	10364431	2034-03-14	U-1919		2019-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-001	10364431	2034-03-14	U-1918		2019-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-001	9506058	2034-03-14	U-1918		2016-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-001	9506058	2034-03-14	U-1919		2016-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-002	RE48468	2028-10-27	U-2097		2021-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-002	RE47769	2029-02-02		Drug product	2019-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-002	10337003	2034-03-14	U-1918		2019-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-002	10364431	2034-03-14	U-1919		2019-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-002	10364431	2034-03-14	U-1918		2019-08-28	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206488-001	ODE-122	2023-09-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206488-002	ODE-122	2023-09-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206488-001	ODE-122	2023-09-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206488-002	ODE-122	2023-09-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206488-001	ODE-122	2023-09-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206488-002	ODE-122	2023-09-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206488-001	NCE	2021-09-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206488-001	ODE-122	2023-09-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206488-002	NCE	2021-09-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206488-002	ODE-122	2023-09-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206488-001	ODE-122	2023-09-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206488-002	ODE-122	2023-09-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206488-001	NCE	2021-09-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206488-001	ODE-122	2023-09-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206488-002	NCE	2021-09-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206488-002	ODE-122	2023-09-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206488-001	NCE	2021-09-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206488-001	ODE-122	2023-09-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206488-002	NCE	2021-09-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206488-002	ODE-122	2023-09-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206488-001	NCE	2021-09-19	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N206488-001	ODE-122	2023-09-19	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N206488-002	NCE	2021-09-19	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N206488-002	ODE-122	2023-09-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206488-001	NCE	2021-09-19	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206488-001	ODE-122	2023-09-19	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206488-002	NCE	2021-09-19	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206488-002	ODE-122	2023-09-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206488-001	NCE	2021-09-19	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206488-001	ODE-122	2023-09-19	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206488-002	NCE	2021-09-19	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206488-002	ODE-122	2023-09-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206488-001	NCE	2021-09-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206488-001	ODE-122	2023-09-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206488-002	NCE	2021-09-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206488-002	ODE-122	2023-09-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206488-001	NCE	2021-09-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206488-001	ODE-122	2023-09-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206488-002	NCE	2021-09-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206488-002	ODE-122	2023-09-19	`b00525d2431f…`

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: Exondys 51
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ETEPLIRSEN	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
AIW6036FAS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1810573	Internal RxNorm lookup
1810578	Internal RxNorm lookup
1810581	Internal RxNorm lookup
1810582	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
33bff678-7829-479e-9110-b8e33a0bc0aa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
4b7700e3-6e0e-45e5-9d22-6f754d61386e	Product name	2	20250304
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
b013b5b7-7902-4c4f-baa9-c13b7d200fa8	Product name	1	20161122
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60923-284-10	2020-02-18	C162847	48780-1	9d75b9d0-9106-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use EXONDYS 51 ® safely and effectively. See full prescribing information for EXONDYS 51. EXONDYS 51 (eteplirsen) injection, for intravenous use Initial U.S. Approval: 2016
60923-284-10	2020-01-31	C162847	48780-1	9d75b9d0-9106-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use EXONDYS 51 ® safely and effectively. See full prescribing information for EXONDYS 51. EXONDYS 51 (eteplirsen) injection, for intravenous use Initial U.S. Approval: 2016

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60923-284-10	Exondys 51	10 mL in 1 VIAL, SINGLE-USE	INJECTION	10		15
60923-284-10	Exondys 51	1 in 1 CARTON	INJECTION	1		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60923-284-10	ML - Milliliter	60923-284	6474b1cb-54b7-4442-b477-086839979038	1	2016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60923-284	EXONDYS 51 (ETEPLIRSEN) INJECTION [SAREPTA THERAPEUTICS, INC.]	13	Current NDC, Legacy NDC, 2 package rows	20250112_33bff678-7829-479e-9110-b8e33a0bc0aa.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Exondys 51	ETEPLIRSEN	Sarepta Therapeutics, Inc.	33bff678-7829-479e-9110-b8e33a0bc0aa	2025-08-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206488 application number: NDA206488 ndc (product): 60923-284

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
AIW6036FAS	ETEPLIRSEN	1173755-55-9	ETEPLIRSEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1810573	eteplirsen 100 MG in 2 ML Injection	PSN	33bff678-7829-479e-9110-b8e33a0bc0aa	15
1810581	eteplirsen 500 MG in 10 ML Injection	PSN	33bff678-7829-479e-9110-b8e33a0bc0aa	15
1810578	Exondys 51, 100 MG in 2 ML Injection	PSN	33bff678-7829-479e-9110-b8e33a0bc0aa	15
1810582	Exondys 51, 500 MG in 10 ML Injection	PSN	33bff678-7829-479e-9110-b8e33a0bc0aa	15
1810582	10 ML eteplirsen 50 MG/ML Injection [Exondys]	SBD	33bff678-7829-479e-9110-b8e33a0bc0aa	15
1810578	2 ML eteplirsen 50 MG/ML Injection [Exondys]	SBD	33bff678-7829-479e-9110-b8e33a0bc0aa	15
1810581	10 ML eteplirsen 50 MG/ML Injection	SCD	33bff678-7829-479e-9110-b8e33a0bc0aa	15
1810573	2 ML eteplirsen 50 MG/ML Injection	SCD	33bff678-7829-479e-9110-b8e33a0bc0aa	15
1810582	10 ML Exondys 50 MG/ML Injection	SY	33bff678-7829-479e-9110-b8e33a0bc0aa	15
1810578	2 ML Exondys 50 MG/ML Injection	SY	33bff678-7829-479e-9110-b8e33a0bc0aa	15
1810573	eteplirsen 100 MG per 2 ML Injection	SY	33bff678-7829-479e-9110-b8e33a0bc0aa	15
1810581	eteplirsen 500 MG per 10 ML Injection	SY	33bff678-7829-479e-9110-b8e33a0bc0aa	15
1810578	Exondys 100 MG per 2 ML Injection	SY	33bff678-7829-479e-9110-b8e33a0bc0aa	15
1810582	Exondys 500 MG per 10 ML Injection	SY	33bff678-7829-479e-9110-b8e33a0bc0aa	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60923-284-10	60923028410	1 VIAL, SINGLE-USE in 1 CARTON (60923-284-10) / 10 mL in 1 VIAL, SINGLE-USE	2016-09-19	0000-00-00	No	No	Current