Jesduvroq

Product NDC: 0173-0897
11-digit product format: 001730897
Labeler code: 0173
Product ID: 0173-0897_d52a823a-35bd-4c6a-a016-4b4f21a43d7d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: daprodustat
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: GlaxoSmithKline LLC
Application: NDA216951
Marketing category: NDA
Marketing start: 2023-02-01
Marketing end: 2027-01-31
Substance: DAPRODUSTAT
Active strength: 1 mg/1
Pharmacologic classes: Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors [MoA], Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC]
NDC exclude flag: No
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	0173-0897	0173-0897-56	D	Discontinued by firm		2026-08-03

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 · 13 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0173-0897-56	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0173-0897-56	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0173-0897-56	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0173-0897-56	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0173-0897-56	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0173-0897-13	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0173-0897-13	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0173-0897-13	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0173-0897-13	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N216951-001	JESDUVROQ	DAPRODUSTAT	1MG	TABLET / ORAL	RLD	2023-02-01
N216951-002	JESDUVROQ	DAPRODUSTAT	2MG	TABLET / ORAL	RLD	2023-02-01
N216951-003	JESDUVROQ	DAPRODUSTAT	4MG	TABLET / ORAL	RLD	2023-02-01
N216951-004	JESDUVROQ	DAPRODUSTAT	6MG	TABLET / ORAL	RLD	2023-02-01
N216951-005	JESDUVROQ	DAPRODUSTAT	8MG	TABLET / ORAL	RLD	2023-02-01

Orange Book patents#

Current patent rows page 1 of 1 · 30 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216951-001	11643397	2027-06-22	U-3535	Drug substance	2023-06-07
N216951-001	8557834	2027-06-22	U-1238		2023-02-21
N216951-001	8815884	2027-06-22	U-1238	Drug product	2023-02-21
N216951-001	8324208	2028-12-11		Drug substance, Drug product	2023-02-21
N216951-001	11117871	2038-03-13	U-3535	Drug substance, Drug product	2023-02-21
N216951-001	11649217	2038-03-13	U-3535	Drug product	2023-06-07
N216951-002	11643397	2027-06-22	U-3535	Drug substance	2023-06-07
N216951-002	8557834	2027-06-22	U-1238		2023-02-21
N216951-002	8815884	2027-06-22	U-1238	Drug product	2023-02-21
N216951-002	8324208	2028-12-11		Drug substance, Drug product	2023-02-21
N216951-002	11117871	2038-03-13	U-3535	Drug substance, Drug product	2023-02-21
N216951-002	11649217	2038-03-13	U-3535	Drug product	2023-06-07
N216951-003	11643397	2027-06-22	U-3535	Drug substance	2023-06-07
N216951-003	8557834	2027-06-22	U-1238		2023-02-21
N216951-003	8815884	2027-06-22	U-1238	Drug product	2023-02-21
N216951-003	8324208	2028-12-11		Drug substance, Drug product	2023-02-21
N216951-003	11117871	2038-03-13	U-3535	Drug substance, Drug product	2023-02-21
N216951-003	11649217	2038-03-13	U-3535	Drug product	2023-06-07
N216951-004	11643397	2027-06-22	U-3535	Drug substance	2023-06-07
N216951-004	8557834	2027-06-22	U-1238		2023-02-21
N216951-004	8815884	2027-06-22	U-1238	Drug product	2023-02-21
N216951-004	8324208	2028-12-11		Drug substance, Drug product	2023-02-21
N216951-004	11117871	2038-03-13	U-3535	Drug substance, Drug product	2023-02-21
N216951-004	11649217	2038-03-13	U-3535	Drug product	2023-06-07
N216951-005	11643397	2027-06-22	U-3535	Drug substance	2023-06-07
N216951-005	8557834	2027-06-22	U-1238		2023-02-21
N216951-005	8815884	2027-06-22	U-1238	Drug product	2023-02-21
N216951-005	8324208	2028-12-11		Drug substance, Drug product	2023-02-21
N216951-005	11117871	2038-03-13	U-3535	Drug substance, Drug product	2023-02-21
N216951-005	11649217	2038-03-13	U-3535	Drug product	2023-06-07

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 5 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216951-001	NCE	2028-02-01
N216951-002	NCE	2028-02-01
N216951-003	NCE	2028-02-01
N216951-004	NCE	2028-02-01
N216951-005	NCE	2028-02-01

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 · 115 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216951-001	JESDUVROQ	1MG	TABLET / ORAL	RLD	2023-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-002	JESDUVROQ	2MG	TABLET / ORAL	RLD	2023-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-003	JESDUVROQ	4MG	TABLET / ORAL	RLD	2023-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-004	JESDUVROQ	6MG	TABLET / ORAL	RLD	2023-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-005	JESDUVROQ	8MG	TABLET / ORAL	RLD	2023-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216951-001	JESDUVROQ	1MG	TABLET / ORAL	RLD	2023-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216951-002	JESDUVROQ	2MG	TABLET / ORAL	RLD	2023-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216951-003	JESDUVROQ	4MG	TABLET / ORAL	RLD	2023-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216951-004	JESDUVROQ	6MG	TABLET / ORAL	RLD	2023-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216951-005	JESDUVROQ	8MG	TABLET / ORAL	RLD	2023-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216951-001	JESDUVROQ	1MG	TABLET / ORAL	RLD	2023-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216951-002	JESDUVROQ	2MG	TABLET / ORAL	RLD	2023-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216951-003	JESDUVROQ	4MG	TABLET / ORAL	RLD	2023-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216951-004	JESDUVROQ	6MG	TABLET / ORAL	RLD	2023-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216951-005	JESDUVROQ	8MG	TABLET / ORAL	RLD	2023-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216951-001	JESDUVROQ	1MG	TABLET / ORAL	RLD	2023-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216951-002	JESDUVROQ	2MG	TABLET / ORAL	RLD	2023-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216951-003	JESDUVROQ	4MG	TABLET / ORAL	RLD	2023-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216951-004	JESDUVROQ	6MG	TABLET / ORAL	RLD	2023-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216951-005	JESDUVROQ	8MG	TABLET / ORAL	RLD	2023-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216951-001	JESDUVROQ	1MG	TABLET / ORAL	RLD	2023-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216951-002	JESDUVROQ	2MG	TABLET / ORAL	RLD	2023-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216951-003	JESDUVROQ	4MG	TABLET / ORAL	RLD	2023-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216951-004	JESDUVROQ	6MG	TABLET / ORAL	RLD	2023-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216951-005	JESDUVROQ	8MG	TABLET / ORAL	RLD	2023-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216951-001	JESDUVROQ	1MG	TABLET / ORAL	RLD	2023-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216951-002	JESDUVROQ	2MG	TABLET / ORAL	RLD	2023-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216951-003	JESDUVROQ	4MG	TABLET / ORAL	RLD	2023-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216951-004	JESDUVROQ	6MG	TABLET / ORAL	RLD	2023-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216951-005	JESDUVROQ	8MG	TABLET / ORAL	RLD	2023-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216951-001	JESDUVROQ	1MG	TABLET / ORAL	RLD	2023-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216951-002	JESDUVROQ	2MG	TABLET / ORAL	RLD	2023-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216951-003	JESDUVROQ	4MG	TABLET / ORAL	RLD	2023-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216951-004	JESDUVROQ	6MG	TABLET / ORAL	RLD	2023-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216951-005	JESDUVROQ	8MG	TABLET / ORAL	RLD	2023-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216951-001	JESDUVROQ	1MG	TABLET / ORAL	RLD	2023-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216951-002	JESDUVROQ	2MG	TABLET / ORAL	RLD	2023-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216951-003	JESDUVROQ	4MG	TABLET / ORAL	RLD	2023-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216951-004	JESDUVROQ	6MG	TABLET / ORAL	RLD	2023-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216951-005	JESDUVROQ	8MG	TABLET / ORAL	RLD	2023-02-01	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 17 · 680 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216951-001	11643397	2027-06-22	U-3535	Drug substance	2023-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-001	8557834	2027-06-22	U-1238		2023-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-001	8815884	2027-06-22	U-1238	Drug product	2023-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-001	8324208	2028-12-11		Drug substance, Drug product	2023-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-001	11117871	2038-03-13	U-3535	Drug substance, Drug product	2023-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-001	11649217	2038-03-13	U-3535	Drug product	2023-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-002	11643397	2027-06-22	U-3535	Drug substance	2023-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-002	8557834	2027-06-22	U-1238		2023-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-002	8815884	2027-06-22	U-1238	Drug product	2023-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-002	8324208	2028-12-11		Drug substance, Drug product	2023-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-002	11117871	2038-03-13	U-3535	Drug substance, Drug product	2023-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-002	11649217	2038-03-13	U-3535	Drug product	2023-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-003	11643397	2027-06-22	U-3535	Drug substance	2023-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-003	8557834	2027-06-22	U-1238		2023-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-003	8815884	2027-06-22	U-1238	Drug product	2023-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-003	8324208	2028-12-11		Drug substance, Drug product	2023-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-003	11117871	2038-03-13	U-3535	Drug substance, Drug product	2023-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-003	11649217	2038-03-13	U-3535	Drug product	2023-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-004	11643397	2027-06-22	U-3535	Drug substance	2023-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-004	8557834	2027-06-22	U-1238		2023-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-004	8815884	2027-06-22	U-1238	Drug product	2023-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-004	8324208	2028-12-11		Drug substance, Drug product	2023-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-004	11117871	2038-03-13	U-3535	Drug substance, Drug product	2023-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-004	11649217	2038-03-13	U-3535	Drug product	2023-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-005	11643397	2027-06-22	U-3535	Drug substance	2023-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-005	8557834	2027-06-22	U-1238		2023-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-005	8815884	2027-06-22	U-1238	Drug product	2023-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-005	8324208	2028-12-11		Drug substance, Drug product	2023-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-005	11117871	2038-03-13	U-3535	Drug substance, Drug product	2023-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-005	11649217	2038-03-13	U-3535	Drug product	2023-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216951-001	11643397	2027-06-22	U-3535	Drug substance	2023-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216951-001	8557834	2027-06-22	U-1238		2023-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216951-001	8815884	2027-06-22	U-1238	Drug product	2023-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216951-001	8324208	2028-12-11		Drug substance, Drug product	2023-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216951-001	11117871	2038-03-13	U-3535	Drug substance, Drug product	2023-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216951-001	11649217	2038-03-13	U-3535	Drug product	2023-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216951-002	11643397	2027-06-22	U-3535	Drug substance	2023-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216951-002	8557834	2027-06-22	U-1238		2023-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216951-002	8815884	2027-06-22	U-1238	Drug product	2023-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216951-002	8324208	2028-12-11		Drug substance, Drug product	2023-02-21	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 115 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216951-001	NCE	2028-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-002	NCE	2028-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-003	NCE	2028-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-004	NCE	2028-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216951-005	NCE	2028-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216951-001	NCE	2028-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216951-002	NCE	2028-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216951-003	NCE	2028-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216951-004	NCE	2028-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216951-005	NCE	2028-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216951-001	NCE	2028-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216951-002	NCE	2028-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216951-003	NCE	2028-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216951-004	NCE	2028-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216951-005	NCE	2028-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216951-001	NCE	2028-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216951-002	NCE	2028-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216951-003	NCE	2028-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216951-004	NCE	2028-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216951-005	NCE	2028-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216951-001	NCE	2028-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216951-002	NCE	2028-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216951-003	NCE	2028-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216951-004	NCE	2028-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216951-005	NCE	2028-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216951-001	NCE	2028-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216951-002	NCE	2028-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216951-003	NCE	2028-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216951-004	NCE	2028-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216951-005	NCE	2028-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216951-001	NCE	2028-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216951-002	NCE	2028-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216951-003	NCE	2028-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216951-004	NCE	2028-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216951-005	NCE	2028-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216951-001	NCE	2028-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216951-002	NCE	2028-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216951-003	NCE	2028-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216951-004	NCE	2028-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216951-005	NCE	2028-02-01	`5bbf6a4d5a75…`

Additional Listing Data#

Finished product: Yes
Brand name base: Jesduvroq

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DAPRODUSTAT	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JVR38ZM64B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2628215	Internal RxNorm lookup
2628221	Internal RxNorm lookup
2628223	Internal RxNorm lookup
2628225	Internal RxNorm lookup
2628227	Internal RxNorm lookup
2628229	Internal RxNorm lookup
2628231	Internal RxNorm lookup
2628233	Internal RxNorm lookup
2628235	Internal RxNorm lookup
2628237	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
d82aa06e-5a33-4844-99b7-4701313455a4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2f584af4-e42b-43ed-abb3-e47eedb1b0c0	Product name	1	20231002

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0173-0897-13	2025-03-13	These highlights do not include all the information needed to use JESDUVROQ safely and effectively. See full prescribing information for JESDUVROQ. JESDUVROQ (daprodustat) tablets, for oral use Initial U.S. Approval: 2023
0173-0897-56	2025-03-13	These highlights do not include all the information needed to use JESDUVROQ safely and effectively. See full prescribing information for JESDUVROQ. JESDUVROQ (daprodustat) tablets, for oral use Initial U.S. Approval: 2023
0173-0897-13	2025-01-30	These highlights do not include all the information needed to use JESDUVROQ safely and effectively. See full prescribing information for JESDUVROQ. JESDUVROQ (daprodustat) tablets, for oral use Initial U.S. Approval: 2023
0173-0897-56	2025-01-30	These highlights do not include all the information needed to use JESDUVROQ safely and effectively. See full prescribing information for JESDUVROQ. JESDUVROQ (daprodustat) tablets, for oral use Initial U.S. Approval: 2023

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0173-0897-13	Jesduvroq	30 in 1 BOTTLE	TABLET, FILM COATED	30	5
0173-0897-56	Jesduvroq	10 in 1 CARTON	TABLET, FILM COATED	10	5
0173-0897-56	Jesduvroq	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0173-0897-13	EA - Each	0173-0897	9083f4e4-7808-4e14-a832-b66095ddc629	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0173-0897	JESDUVROQ (DAPRODUSTAT) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	5	Current NDC, 3 package rows	20250316_d82aa06e-5a33-4844-99b7-4701313455a4.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
Jesduvroq	DAPRODUSTAT	GlaxoSmithKline LLC	d82aa06e-5a33-4844-99b7-4701313455a4	2023-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216951 application number: NDA216951 ndc (product): 0173-0897

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JVR38ZM64B	DAPRODUSTAT	960539-70-2	DAPRODUSTAT

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2628215	daprodustat 1 MG Oral Tablet	PSN	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628223	daprodustat 2 MG Oral Tablet	PSN	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628227	daprodustat 4 MG Oral Tablet	PSN	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628231	daprodustat 6 MG Oral Tablet	PSN	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628235	daprodustat 8 MG Oral Tablet	PSN	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628221	Jesduvroq 1 MG Oral Tablet	PSN	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628225	Jesduvroq 2 MG Oral Tablet	PSN	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628229	Jesduvroq 4 MG Oral Tablet	PSN	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628233	Jesduvroq 6 MG Oral Tablet	PSN	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628237	Jesduvroq 8 MG Oral Tablet	PSN	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628221	daprodustat 1 MG Oral Tablet [Jesduvroq]	SBD	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628225	daprodustat 2 MG Oral Tablet [Jesduvroq]	SBD	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628229	daprodustat 4 MG Oral Tablet [Jesduvroq]	SBD	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628233	daprodustat 6 MG Oral Tablet [Jesduvroq]	SBD	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628237	daprodustat 8 MG Oral Tablet [Jesduvroq]	SBD	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628215	daprodustat 1 MG Oral Tablet	SCD	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628223	daprodustat 2 MG Oral Tablet	SCD	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628227	daprodustat 4 MG Oral Tablet	SCD	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628231	daprodustat 6 MG Oral Tablet	SCD	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628235	daprodustat 8 MG Oral Tablet	SCD	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628221	Jesduvroq 1 MG Oral Tablet	SY	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628225	Jesduvroq 2 MG Oral Tablet	SY	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628229	Jesduvroq 4 MG Oral Tablet	SY	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628233	Jesduvroq 6 MG Oral Tablet	SY	d82aa06e-5a33-4844-99b7-4701313455a4	5
2628237	Jesduvroq 8 MG Oral Tablet	SY	d82aa06e-5a33-4844-99b7-4701313455a4	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0173-0897-13	00173089713	30 TABLET, FILM COATED in 1 BOTTLE (0173-0897-13)	2023-02-01	2027-01-31	No	No	Historical
0173-0897-56	00173089756	10 in 1 CARTON					Historical