VAFSEO

Product NDC: 59922-643
Requested package NDC: 59922-643-60
11-digit product format: 599220643
Labeler code: 59922
Product ID: 59922-643_400c5380-cfe8-4495-bdd0-12608d197860
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Vadadustat
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Akebia Therapeutics, Inc.
Application: NDA215192
Marketing category: NDA
Marketing start: 2024-03-28
Substance: VADADUSTAT
Active strength: 450 mg/1
Pharmacologic classes: Breast Cancer Resistance Protein Inhibitors [MoA], Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors [MoA], Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC], Organic Anion Transporter 3 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215192-001	VAFSEO	VADADUSTAT	150MG	TABLET / ORAL	RLD	2024-03-27
N215192-002	VAFSEO	VADADUSTAT	300MG	TABLET / ORAL	RLD	2024-03-27
N215192-003	VAFSEO	VADADUSTAT	450MG	TABLET / ORAL	RLD	2024-03-27

Orange Book patents#

Current patent rows page 1 of 1 · 42 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215192-001	8598210	2027-06-26		Drug substance, Drug product	2024-04-10
N215192-001	8940773	2027-06-26	U-3876		2024-04-10
N215192-001	RE47437	2027-06-26		Drug substance, Drug product	2024-04-10
N215192-001	8343952	2027-08-14		Drug substance, Drug product	2024-04-10
N215192-001	7811595	2028-03-13		Drug substance, Drug product	2024-04-10
N215192-001	8323671	2028-04-03	U-3876		2024-04-10
N215192-001	12569474	2034-06-04	U-3876		2026-03-25
N215192-001	11857543	2034-06-09	U-3876		2024-04-10
N215192-001	10149842	2034-11-14		Drug substance, Drug product	2024-04-10
N215192-001	11065237	2034-11-14	U-3876	Drug substance, Drug product	2024-04-10
N215192-001	9701636	2034-11-14		Drug substance, Drug product	2024-04-10
N215192-001	9987262	2034-11-14	U-3876		2024-04-10
N215192-001	11324734	2036-03-31		Drug product	2024-04-10
N215192-001	11844756	2036-03-31	U-3876		2024-04-10
N215192-002	8598210	2027-06-26		Drug substance, Drug product	2024-04-10
N215192-002	8940773	2027-06-26	U-3876		2024-04-10
N215192-002	RE47437	2027-06-26		Drug substance, Drug product	2024-04-10
N215192-002	8343952	2027-08-14		Drug substance, Drug product	2024-04-10
N215192-002	7811595	2028-03-13		Drug substance, Drug product	2024-04-10
N215192-002	8323671	2028-04-03	U-3876		2024-04-10
N215192-002	12569474	2034-06-04	U-3876		2026-03-25
N215192-002	11857543	2034-06-09	U-3876		2024-04-10
N215192-002	10149842	2034-11-14		Drug substance, Drug product	2024-04-10
N215192-002	11065237	2034-11-14	U-3876	Drug substance, Drug product	2024-04-10
N215192-002	9701636	2034-11-14		Drug substance, Drug product	2024-04-10
N215192-002	9987262	2034-11-14	U-3876		2024-04-10
N215192-002	11324734	2036-03-31		Drug product	2024-04-10
N215192-002	11844756	2036-03-31	U-3876		2024-04-10
N215192-003	8598210	2027-06-26		Drug substance, Drug product	2024-04-10
N215192-003	8940773	2027-06-26	U-3876		2024-04-10
N215192-003	RE47437	2027-06-26		Drug substance, Drug product	2024-04-10
N215192-003	8343952	2027-08-14		Drug substance, Drug product	2024-04-10
N215192-003	7811595	2028-03-13		Drug substance, Drug product	2024-04-10
N215192-003	8323671	2028-04-03	U-3876		2024-04-10
N215192-003	12569474	2034-06-04	U-3876		2026-03-25
N215192-003	11857543	2034-06-09	U-3876		2024-04-10
N215192-003	10149842	2034-11-14		Drug substance, Drug product	2024-04-10
N215192-003	11065237	2034-11-14	U-3876	Drug substance, Drug product	2024-04-10
N215192-003	9701636	2034-11-14		Drug substance, Drug product	2024-04-10
N215192-003	9987262	2034-11-14	U-3876		2024-04-10
N215192-003	11324734	2036-03-31		Drug product	2024-04-10
N215192-003	11844756	2036-03-31	U-3876		2024-04-10

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215192-001	NCE	2029-03-27
N215192-002	NCE	2029-03-27
N215192-003	NCE	2029-03-27

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 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD	2024-03-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD	2024-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD, RS	2024-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD, RS	2024-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD, RS	2024-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD, RS	2024-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD, RS	2024-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD, RS	2024-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD, RS	2024-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD, RS	2024-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD, RS	2024-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD, RS	2024-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD, RS	2024-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`79d66fd596c7…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 714 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N215192-001	8598210	2027-06-26		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	8940773	2027-06-26	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	RE47437	2027-06-26		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	8343952	2027-08-14		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	7811595	2028-03-13		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	8323671	2028-04-03	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	12569474	2034-06-04	U-3876		2026-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	11857543	2034-06-09	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	10149842	2034-11-14		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	11065237	2034-11-14	U-3876	Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	9701636	2034-11-14		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	9987262	2034-11-14	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	11324734	2036-03-31		Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	11844756	2036-03-31	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	8598210	2027-06-26		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	8940773	2027-06-26	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	RE47437	2027-06-26		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	8343952	2027-08-14		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	7811595	2028-03-13		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	8323671	2028-04-03	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	12569474	2034-06-04	U-3876		2026-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	11857543	2034-06-09	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	10149842	2034-11-14		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	11065237	2034-11-14	U-3876	Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	9701636	2034-11-14		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	9987262	2034-11-14	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	11324734	2036-03-31		Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	11844756	2036-03-31	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	8598210	2027-06-26		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	8940773	2027-06-26	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	RE47437	2027-06-26		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	8343952	2027-08-14		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	7811595	2028-03-13		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	8323671	2028-04-03	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	12569474	2034-06-04	U-3876		2026-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	11857543	2034-06-09	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	10149842	2034-11-14		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	11065237	2034-11-14	U-3876	Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	9701636	2034-11-14		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	9987262	2034-11-14	U-3876		2024-04-10	`c2088c7a36db…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N215192-001	NCE	2029-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	NCE	2029-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	NCE	2029-03-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N215192-001	NCE	2029-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215192-002	NCE	2029-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215192-003	NCE	2029-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215192-001	NCE	2029-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215192-002	NCE	2029-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215192-003	NCE	2029-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215192-001	NCE	2029-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215192-002	NCE	2029-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215192-003	NCE	2029-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215192-001	NCE	2029-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215192-002	NCE	2029-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215192-003	NCE	2029-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215192-001	NCE	2029-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215192-002	NCE	2029-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215192-003	NCE	2029-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215192-001	NCE	2029-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215192-002	NCE	2029-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215192-003	NCE	2029-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215192-001	NCE	2029-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215192-002	NCE	2029-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215192-003	NCE	2029-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215192-001	NCE	2029-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215192-002	NCE	2029-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215192-003	NCE	2029-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215192-001	NCE	2029-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215192-002	NCE	2029-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215192-003	NCE	2029-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215192-001	NCE	2029-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215192-002	NCE	2029-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215192-003	NCE	2029-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215192-001	NCE	2029-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215192-002	NCE	2029-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215192-003	NCE	2029-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215192-001	NCE	2029-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215192-002	NCE	2029-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215192-003	NCE	2029-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215192-001	NCE	2029-03-27	`79d66fd596c7…`

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: VAFSEO
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VADADUSTAT	450 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
I60W9520VV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2679301	Internal RxNorm lookup
2679307	Internal RxNorm lookup
2679309	Internal RxNorm lookup
2679311	Internal RxNorm lookup
2679313	Internal RxNorm lookup
2679315	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
ac9da724-5a62-4ab6-a89c-376a25f6195b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5dad82fb-e12f-4ab2-91b3-3f8402309a44	Product name	1	20250128

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59922-643-60	VAFSEO	60 in 1 BOTTLE	TABLET, FILM COATED	60		4
59922-643-60	VAFSEO	1 in 1 CARTON	TABLET, FILM COATED	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59922-643	VAFSEO (VADADUSTAT) TABLET, FILM COATED [AKEBIA THERAPEUTICS, INC.]	3	Current NDC, 2 package rows	20241222_ac9da724-5a62-4ab6-a89c-376a25f6195b.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
VAFSEO	VADADUSTAT	Akebia Therapeutics, Inc.	ac9da724-5a62-4ab6-a89c-376a25f6195b	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215192 application number: NDA215192 ndc (package): 59922-643-60 ndc (product): 59922-643 ndc11 (package): 59922064360

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I60W9520VV	VADADUSTAT	1000025-07-9	VADADUSTAT

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2679301	vadadustat 150 MG Oral Tablet	PSN	ac9da724-5a62-4ab6-a89c-376a25f6195b	4
2679309	vadadustat 300 MG Oral Tablet	PSN	ac9da724-5a62-4ab6-a89c-376a25f6195b	4
2679313	vadadustat 450 MG Oral Tablet	PSN	ac9da724-5a62-4ab6-a89c-376a25f6195b	4
2679307	Vafseo 150 MG Oral Tablet	PSN	ac9da724-5a62-4ab6-a89c-376a25f6195b	4
2679311	Vafseo 300 MG Oral Tablet	PSN	ac9da724-5a62-4ab6-a89c-376a25f6195b	4
2679315	Vafseo 450 MG Oral Tablet	PSN	ac9da724-5a62-4ab6-a89c-376a25f6195b	4
2679307	vadadustat 150 MG Oral Tablet [Vafseo]	SBD	ac9da724-5a62-4ab6-a89c-376a25f6195b	4
2679311	vadadustat 300 MG Oral Tablet [Vafseo]	SBD	ac9da724-5a62-4ab6-a89c-376a25f6195b	4
2679315	vadadustat 450 MG Oral Tablet [Vafseo]	SBD	ac9da724-5a62-4ab6-a89c-376a25f6195b	4
2679301	vadadustat 150 MG Oral Tablet	SCD	ac9da724-5a62-4ab6-a89c-376a25f6195b	4
2679309	vadadustat 300 MG Oral Tablet	SCD	ac9da724-5a62-4ab6-a89c-376a25f6195b	4
2679313	vadadustat 450 MG Oral Tablet	SCD	ac9da724-5a62-4ab6-a89c-376a25f6195b	4
2679301	vadadustat 150 MG Oral Tablet	SY	ac9da724-5a62-4ab6-a89c-376a25f6195b	4
2679309	vadadustat 300 MG Oral Tablet	SY	ac9da724-5a62-4ab6-a89c-376a25f6195b	4
2679313	vadadustat 450 MG Oral Tablet	SY	ac9da724-5a62-4ab6-a89c-376a25f6195b	4
2679307	Vafseo 150 MG Oral Tablet	SY	ac9da724-5a62-4ab6-a89c-376a25f6195b	4
2679311	Vafseo 300 MG Oral Tablet	SY	ac9da724-5a62-4ab6-a89c-376a25f6195b	4
2679315	Vafseo 450 MG Oral Tablet	SY	ac9da724-5a62-4ab6-a89c-376a25f6195b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
59922-643-60	59922064360	1 BOTTLE in 1 CARTON (59922-643-60) / 60 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2024-03-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VAFSEO	Akebia Therapeutics, Inc. \| Changzhou SynTheAll Pharmaceutical Co., Ltd \| Esteve Quimica, S.A. \| Patheon Inc. \| Shanghai STA Pharmaceutical Product Co., Ltd.	2026-03-30	HUMAN PRESCRIPTION DRUG LABEL	4