Veklury

Product NDC: 61958-2901
Requested package NDC: 61958-2901-1
11-digit product format: 619582901
Labeler code: 61958
Product ID: 61958-2901_2399f66f-aacb-4743-8117-b722c91b4bac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: remdesivir
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Gilead Sciences, Inc.
Application: NDA214787
Marketing category: NDA
Marketing start: 2020-11-01
Substance: REMDESIVIR
Active strength: 100 mg/1
Pharmacologic classes: SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61958-2901	61958-2901-1	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N214787-001	VEKLURY	REMDESIVIR	100MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2020-10-22
N214787-002	VEKLURY	REMDESIVIR	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD	2020-10-22

Orange Book patents#

Current patent rows page 1 of 1 · 71 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214787-001	8318682	2029-04-22		Drug substance, Drug product	2020-11-12
N214787-001	RE46762	2029-04-22		Drug substance, Drug product	2020-11-12
N214787-001	8008264	2029-09-06		Drug substance, Drug product	2020-11-12
N214787-001	8318682*PED	2029-10-22		Pediatric extension
N214787-001	RE46762*PED	2029-10-22		Pediatric extension
N214787-001	8008264*PED	2030-03-06		Pediatric extension
N214787-001	11492353	2031-12-08		Drug substance	2022-12-06
N214787-001	11492353*PED	2032-06-08		Pediatric extension
N214787-001	10065958	2032-11-18		Drug substance	2020-11-12
N214787-001	10065958*PED	2033-05-18		Pediatric extension
N214787-001	9724360	2035-10-29		Drug substance, Drug product	2020-11-12
N214787-001	9949994	2035-10-29		Drug substance	2020-11-12
N214787-001	9724360*PED	2036-04-29		Pediatric extension
N214787-001	9949994*PED	2036-04-29		Pediatric extension
N214787-001	10695361	2036-09-16	U-3831		2020-11-12
N214787-001	10695361	2036-09-16	U-3832		2020-11-12
N214787-001	11007208	2036-09-16	U-3831		2021-06-15
N214787-001	11007208	2036-09-16	U-3832		2021-06-15
N214787-001	11382926	2036-09-16	U-3831		2022-08-02
N214787-001	11382926	2036-09-16	U-3832		2022-08-02
N214787-001	10695361*PED	2037-03-16		Pediatric extension
N214787-001	11007208*PED	2037-03-16		Pediatric extension
N214787-001	11382926*PED	2037-03-16		Pediatric extension
N214787-001	10675296	2038-07-10		Drug product	2020-11-12
N214787-001	11266681	2038-07-10	U-3831		2022-04-04
N214787-001	11266681	2038-07-10	U-3832		2022-04-04
N214787-001	11975017	2038-07-10		Drug product	2024-06-05
N214787-001	10675296*PED	2039-01-10		Pediatric extension
N214787-001	11266681*PED	2039-01-10		Pediatric extension
N214787-001	11975017*PED	2039-01-10		Pediatric extension
N214787-001	11491169	2041-05-28	U-3835		2022-12-06
N214787-001	11491169	2041-05-28	U-3836		2022-12-06
N214787-001	11903953	2041-05-28	U-3835		2024-03-19
N214787-001	11903953	2041-05-28	U-3836		2024-03-19
N214787-001	11975012	2041-05-28	U-3835		2024-06-05
N214787-001	11975012	2041-05-28	U-3836		2024-06-05
N214787-001	11491169*PED	2041-11-28		Pediatric extension
N214787-001	11903953*PED	2041-11-28		Pediatric extension
N214787-001	11975012*PED	2041-11-28		Pediatric extension
N214787-002	8318682	2029-04-22		Drug substance, Drug product	2020-11-12
N214787-002	RE46762	2029-04-22		Drug substance, Drug product	2020-11-12
N214787-002	8008264	2029-09-06		Drug substance, Drug product	2020-11-12
N214787-002	8318682*PED	2029-10-22		Pediatric extension
N214787-002	RE46762*PED	2029-10-22		Pediatric extension
N214787-002	8008264*PED	2030-03-06		Pediatric extension
N214787-002	11492353	2031-12-08		Drug substance	2022-12-06
N214787-002	11492353*PED	2032-06-08		Pediatric extension
N214787-002	10065958	2032-11-18		Drug substance	2020-11-12
N214787-002	10065958*PED	2033-05-18		Pediatric extension
N214787-002	9724360	2035-10-29		Drug substance, Drug product	2020-11-12
N214787-002	9949994	2035-10-29		Drug substance	2020-11-12
N214787-002	9724360*PED	2036-04-29		Pediatric extension
N214787-002	9949994*PED	2036-04-29		Pediatric extension
N214787-002	10695361	2036-09-16	U-3829		2020-11-12
N214787-002	10695361	2036-09-16	U-3830		2020-11-12
N214787-002	11007208	2036-09-16	U-3829		2021-06-15
N214787-002	11007208	2036-09-16	U-3830		2021-06-15
N214787-002	11382926	2036-09-16	U-3829		2022-08-02
N214787-002	11382926	2036-09-16	U-3830		2022-08-02
N214787-002	10695361*PED	2037-03-16		Pediatric extension
N214787-002	11007208*PED	2037-03-16		Pediatric extension
N214787-002	11382926*PED	2037-03-16		Pediatric extension
N214787-002	11491169	2041-05-28	U-3833		2022-12-06
N214787-002	11491169	2041-05-28	U-3834		2022-12-06
N214787-002	11903953	2041-05-28	U-3833		2024-03-19
N214787-002	11903953	2041-05-28	U-3834		2024-03-19
N214787-002	11975012	2041-05-28	U-3833		2024-06-05
N214787-002	11975012	2041-05-28	U-3834		2024-06-05
N214787-002	11491169*PED	2041-11-28		Pediatric extension
N214787-002	11903953*PED	2041-11-28		Pediatric extension
N214787-002	11975012*PED	2041-11-28		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214787-001	NCE	2025-10-22
N214787-001	PED	2026-04-22
N214787-001	M-301	2026-07-13
N214787-001	PED	2027-01-13
N214787-002	NCE	2025-10-22
N214787-002	PED	2026-04-22
N214787-002	M-301	2026-07-13
N214787-002	PED	2027-01-13

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 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 49 · 1,943 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214787-001	8318682	2029-04-22		Drug substance, Drug product	2020-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	RE46762	2029-04-22		Drug substance, Drug product	2020-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	8008264	2029-09-06		Drug substance, Drug product	2020-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	8318682*PED	2029-10-22		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	RE46762*PED	2029-10-22		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	8008264*PED	2030-03-06		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	11492353	2031-12-08		Drug substance	2022-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	11492353*PED	2032-06-08		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	10065958	2032-11-18		Drug substance	2020-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	10065958*PED	2033-05-18		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	9724360	2035-10-29		Drug substance, Drug product	2020-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	9949994	2035-10-29		Drug substance	2020-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	9724360*PED	2036-04-29		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	9949994*PED	2036-04-29		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	10695361	2036-09-16	U-3831		2020-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	10695361	2036-09-16	U-3832		2020-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	11007208	2036-09-16	U-3831		2021-06-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	11007208	2036-09-16	U-3832		2021-06-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	11382926	2036-09-16	U-3831		2022-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	11382926	2036-09-16	U-3832		2022-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	10695361*PED	2037-03-16		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	11007208*PED	2037-03-16		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	11382926*PED	2037-03-16		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	10675296	2038-07-10		Drug product	2020-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	11266681	2038-07-10	U-3832		2022-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	11266681	2038-07-10	U-3831		2022-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	11975017	2038-07-10		Drug product	2024-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	10675296*PED	2039-01-10		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	11266681*PED	2039-01-10		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	11975017*PED	2039-01-10		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	11491169	2041-05-28	U-3836		2022-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	11491169	2041-05-28	U-3835		2022-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	11903953	2041-05-28	U-3835		2024-03-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	11903953	2041-05-28	U-3836		2024-03-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	11975012	2041-05-28	U-3835		2024-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	11975012	2041-05-28	U-3836		2024-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	11491169*PED	2041-11-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	11903953*PED	2041-11-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	11975012*PED	2041-11-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-002	8318682	2029-04-22		Drug substance, Drug product	2020-11-12	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 9 · 360 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N214787-001	NCE	2025-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	PED	2026-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	M-301	2026-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-001	PED	2027-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-002	NCE	2025-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-002	PED	2026-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-002	M-301	2026-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214787-002	PED	2027-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214787-001	NCE	2025-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	PED	2026-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	M-301	2026-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	PED	2027-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-002	NCE	2025-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-002	PED	2026-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-002	M-301	2026-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-002	PED	2027-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-001	D-183	2025-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-001	NPP	2025-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-001	PED	2025-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-001	NCE	2025-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-001	PED	2025-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-001	PED	2026-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-001	M-301	2026-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-001	PED	2027-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-002	D-183	2025-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-002	NPP	2025-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-002	PED	2025-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-002	NCE	2025-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-002	PED	2025-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-002	PED	2026-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-002	M-301	2026-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-002	PED	2027-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214787-001	D-183	2025-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-001	NPP	2025-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-001	PED	2025-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-001	NCE	2025-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-001	PED	2025-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-001	PED	2026-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-001	M-301	2026-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-001	PED	2027-01-13	`6a471c1ec25d…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
REMDESIVIR	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3QKI37EEHE	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2284960	Internal RxNorm lookup
2367758	Internal RxNorm lookup
2395502	Internal RxNorm lookup
2395504	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
c0978fa8-53ff-4ca2-82a7-567fd3e958ca	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
99dff68f-b615-4e99-a38a-c795f81730ef	Product name	1	20210517

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61958-2901-2	Veklury	1 in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	1		23
61958-2901-2	Veklury	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61958-2901-1	EA - Each	61958-2901	00cbb0d1-e8a5-410f-a0ac-69f7579a76bb	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61958-2901	VEKLURY (REMDESIVIR) INJECTION VEKLURY (REMDESIVIR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GILEAD SCIENCES, INC.]	20	Current NDC, Legacy NDC, 2 package rows	20250126_c0978fa8-53ff-4ca2-82a7-567fd3e958ca.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
Veklury	REMDESIVIR	Gilead Sciences, Inc.	c0978fa8-53ff-4ca2-82a7-567fd3e958ca	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214787 application number: NDA214787 ndc (product): 61958-2901

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3QKI37EEHE	REMDESIVIR	1809249-37-3	REMDESIVIR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2367758	remdesivir 100 MG in 20 mL Injection	PSN	c0978fa8-53ff-4ca2-82a7-567fd3e958ca	23
2284960	remdesivir 100 MG Injection	PSN	c0978fa8-53ff-4ca2-82a7-567fd3e958ca	23
2395504	Veklury 100 MG in 20 mL Injection	PSN	c0978fa8-53ff-4ca2-82a7-567fd3e958ca	23
2395502	Veklury 100 MG Injection	PSN	c0978fa8-53ff-4ca2-82a7-567fd3e958ca	23
2395504	20 ML remdesivir 5 MG/ML Injection [Veklury]	SBD	c0978fa8-53ff-4ca2-82a7-567fd3e958ca	23
2395502	remdesivir 100 MG Injection [Veklury]	SBD	c0978fa8-53ff-4ca2-82a7-567fd3e958ca	23
2367758	20 ML remdesivir 5 MG/ML Injection	SCD	c0978fa8-53ff-4ca2-82a7-567fd3e958ca	23
2284960	remdesivir 100 MG Injection	SCD	c0978fa8-53ff-4ca2-82a7-567fd3e958ca	23
2395504	20 ML Veklury 5 MG/ML Injection	SY	c0978fa8-53ff-4ca2-82a7-567fd3e958ca	23
2367758	remdesivir 100 MG per 20 ML Injection	SY	c0978fa8-53ff-4ca2-82a7-567fd3e958ca	23
2395502	Veklury 100 MG Injection	SY	c0978fa8-53ff-4ca2-82a7-567fd3e958ca	23
2395504	Veklury 100 MG per 20 ML Injection	SY	c0978fa8-53ff-4ca2-82a7-567fd3e958ca	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61958-2901-1	61958290101	1 VIAL, SINGLE-DOSE in 1 CARTON (61958-2901-1) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2020-05-01	2023-09-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Veklury	Gilead Sciences, Inc.	2026-07-29	HUMAN PRESCRIPTION DRUG LABEL	24
Veklury	Gilead Sciences, Inc.	2022-01-27	HUMAN PRESCRIPTION DRUG LABEL	8