Viltepso

Product NDC: 73292-011
11-digit product format: 732920011
Labeler code: 73292
Product ID: 73292-011_0e3b8e29-64dd-430f-998d-5aca82258a8d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: viltolarsen
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: NS Pharma, Inc.
Application: NDA212154
Marketing category: NDA
Marketing start: 2020-08-13
Substance: VILTOLARSEN
Active strength: 250 mg/1
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N212154-001	VILTEPSO	VILTOLARSEN	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-08-12

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212154-001	10870676	2031-08-31	U-3039	Drug substance, Drug product	2021-01-15
N212154-001	9079934	2034-04-03		Drug substance, Drug product	2020-09-09

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212154-001	ODE-280	2027-08-12

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212154-001	VILTEPSO	250MG/5ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-08-12	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 76 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	N212154-001	10870676	2031-08-31	U-3039	Drug substance, Drug product	2021-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212154-001	9079934	2034-04-03		Drug substance, Drug product	2020-09-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212154-001	10870676	2031-08-31	U-3039	Drug substance, Drug product	2021-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212154-001	9079934	2034-04-03		Drug substance, Drug product	2020-09-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212154-001	10870676	2031-08-31	U-3039	Drug substance, Drug product	2021-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212154-001	9079934	2034-04-03		Drug substance, Drug product	2020-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212154-001	10870676	2031-08-31	U-3039	Drug substance, Drug product	2021-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212154-001	9079934	2034-04-03		Drug substance, Drug product	2020-09-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212154-001	10870676	2031-08-31	U-3039	Drug substance, Drug product	2021-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212154-001	9079934	2031-08-31		Drug substance, Drug product	2020-09-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212154-001	10870676	2031-08-31	U-3039	Drug substance, Drug product	2021-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212154-001	9079934	2031-08-31		Drug substance, Drug product	2020-09-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212154-001	10870676	2031-08-31	U-3039	Drug substance, Drug product	2021-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212154-001	9079934	2031-08-31		Drug substance, Drug product	2020-09-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212154-001	10870676	2031-08-31	U-3039	Drug substance, Drug product	2021-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212154-001	9079934	2031-08-31		Drug substance, Drug product	2020-09-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212154-001	10870676	2031-08-31	U-3039	Drug substance, Drug product	2021-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212154-001	9079934	2031-08-31		Drug substance, Drug product	2020-09-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212154-001	10870676	2031-08-31	U-3039	Drug substance, Drug product	2021-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212154-001	9079934	2031-08-31		Drug substance, Drug product	2020-09-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212154-001	10870676	2031-08-31	U-3039	Drug substance, Drug product	2021-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212154-001	9079934	2031-08-31		Drug substance, Drug product	2020-09-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212154-001	10870676	2031-08-31	U-3039	Drug substance, Drug product	2021-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212154-001	9079934	2031-08-31		Drug substance, Drug product	2020-09-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212154-001	10870676	2031-08-31	U-3039	Drug substance, Drug product	2021-01-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212154-001	9079934	2031-08-31		Drug substance, Drug product	2020-09-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212154-001	10870676	2031-08-31	U-3039	Drug substance, Drug product	2021-01-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212154-001	9079934	2031-08-31		Drug substance, Drug product	2020-09-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212154-001	10870676	2031-08-31	U-3039	Drug substance, Drug product	2021-01-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212154-001	9079934	2031-08-31		Drug substance, Drug product	2020-09-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212154-001	10870676	2031-08-31	U-3039	Drug substance, Drug product	2021-01-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N212154-001	9079934	2031-08-31		Drug substance, Drug product	2020-09-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212154-001	10870676	2031-08-31	U-3039	Drug substance, Drug product	2021-01-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212154-001	9079934	2031-08-31		Drug substance, Drug product	2020-09-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212154-001	10870676	2031-08-31	U-3039	Drug substance, Drug product	2021-01-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212154-001	9079934	2031-08-31		Drug substance, Drug product	2020-09-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212154-001	10870676	2031-08-31	U-3039	Drug substance, Drug product	2021-01-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212154-001	9079934	2031-08-31		Drug substance, Drug product	2020-09-09	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212154-001	10870676	2031-08-31	U-3039	Drug substance, Drug product	2021-01-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212154-001	9079934	2031-08-31		Drug substance, Drug product	2020-09-09	`bb7c543d1eb4…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N212154-001	ODE-280	2027-08-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212154-001	ODE-280	2027-08-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212154-001	ODE-280	2027-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212154-001	NCE	2025-08-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212154-001	ODE-280	2027-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212154-001	NCE	2025-08-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212154-001	ODE-280	2027-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212154-001	NCE	2025-08-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212154-001	ODE-280	2027-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212154-001	NCE	2025-08-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212154-001	ODE-280	2027-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212154-001	NCE	2025-08-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212154-001	ODE-280	2027-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212154-001	NCE	2025-08-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212154-001	ODE-280	2027-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212154-001	NCE	2025-08-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212154-001	ODE-280	2027-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212154-001	NCE	2025-08-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212154-001	ODE-280	2027-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212154-001	NCE	2025-08-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212154-001	ODE-280	2027-08-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212154-001	NCE	2025-08-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212154-001	ODE-280	2027-08-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212154-001	NCE	2025-08-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212154-001	ODE-280	2027-08-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212154-001	NCE	2025-08-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212154-001	ODE-280	2027-08-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212154-001	NCE	2025-08-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N212154-001	ODE-280	2027-08-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212154-001	NCE	2025-08-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212154-001	ODE-280	2027-08-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212154-001	NCE	2025-08-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212154-001	ODE-280	2027-08-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212154-001	NCE	2025-08-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212154-001	ODE-280	2027-08-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212154-001	NCE	2025-08-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212154-001	ODE-280	2027-08-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212154-001	NCE	2025-08-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N212154-001	ODE-280	2027-08-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212154-001	NCE	2025-08-12	`87673890dc5c…`

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: Viltepso
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VILTOLARSEN	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SXA7YP6EKX	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2389844	Internal RxNorm lookup
2389849	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
1ffff9a8-6d6a-4dcb-8493-1b6cc3a5d123	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
93e62457-5676-4d42-8901-2577d3b63619	Product name	1	20210309
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
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
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	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
b060cc1a-fe47-856b-0b77-4448b5963de8	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73292-011-01	Viltepso	1 in 1 CARTON	INJECTION, SOLUTION	1		7
73292-011-01	Viltepso	1 in 1 VIAL, GLASS	INJECTION, SOLUTION	1		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73292-011	VILTEPSO (VILTOLARSEN) INJECTION, SOLUTION [NS PHARMA, INC.]	6	Current NDC, Legacy NDC, 2 package rows	20230803_1ffff9a8-6d6a-4dcb-8493-1b6cc3a5d123.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
Viltepso	VILTOLARSEN	NS Pharma, Inc.	1ffff9a8-6d6a-4dcb-8493-1b6cc3a5d123	2025-07-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212154 application number: NDA212154 ndc (product): 73292-011

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SXA7YP6EKX	VILTOLARSEN	2055732-84-6	VILTOLARSEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2389849	VILTEPSO 250 MG in 5 mL Injection	PSN	1ffff9a8-6d6a-4dcb-8493-1b6cc3a5d123	7
2389844	viltolarsen 250 MG in 5 ML Injection	PSN	1ffff9a8-6d6a-4dcb-8493-1b6cc3a5d123	7
2389849	5 ML viltolarsen 50 MG/ML Injection [Viltepso]	SBD	1ffff9a8-6d6a-4dcb-8493-1b6cc3a5d123	7
2389844	5 ML viltolarsen 50 MG/ML Injection	SCD	1ffff9a8-6d6a-4dcb-8493-1b6cc3a5d123	7
2389849	5 ML Viltepso 50 MG/ML Injection	SY	1ffff9a8-6d6a-4dcb-8493-1b6cc3a5d123	7
2389849	Viltepso 250 MG per 5 mL Injection	SY	1ffff9a8-6d6a-4dcb-8493-1b6cc3a5d123	7
2389844	viltolarsen 250 MG per 5 ML Injection	SY	1ffff9a8-6d6a-4dcb-8493-1b6cc3a5d123	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
73292-011-01	73292001101	1 VIAL, GLASS in 1 CARTON (73292-011-01) / 1 INJECTION, SOLUTION in 1 VIAL, GLASS	2020-08-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Viltepso	NS Pharma, Inc. \| Ajinomoto Co., Inc. \| AndersonBrecon Inc. \| Fuji Yakuhin Co., Ltd. \| YMC Co., Ltd.	2025-07-16	HUMAN PRESCRIPTION DRUG LABEL	7