VELTASSA

Product NDC: 53436-168
11-digit product format: 534360168
Labeler code: 53436
Product ID: 53436-168_3e4b6452-1c7c-4f58-aee4-12fb185aaa83
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: patiromer
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Vifor Pharma, Inc.
Application: NDA205739
Marketing category: NDA
Marketing start: 2015-10-23
Substance: PATIROMER
Active strength: 16.8 g/1
Pharmacologic classes: Potassium Binder [EPC], Potassium Ion Binding Activity [MoA]
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N205739-001	VELTASSA	PATIROMER SORBITEX CALCIUM	EQ 8.4GM BASE/PACKET	POWDER / ORAL	RLD	2015-10-21
N205739-002	VELTASSA	PATIROMER SORBITEX CALCIUM	EQ 16.8GM BASE/PACKET	POWDER / ORAL	RLD, RS	2015-10-21
N205739-003	VELTASSA	PATIROMER SORBITEX CALCIUM	EQ 25.2GM BASE/PACKET	POWDER / ORAL	RLD	2015-10-21
N205739-004	VELTASSA	PATIROMER SORBITEX CALCIUM	EQ 1GM BASE/PACKET	POWDER / ORAL	RLD	2023-10-02

Orange Book patents#

Current patent rows page 1 of 1 · 28 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205739-001	8216560	2027-03-14	U-1766		2015-11-18
N205739-001	8282913	2027-05-29		Drug product	2015-11-18
N205739-001	8147873	2028-06-20		Drug product	2015-11-18
N205739-001	8337824	2030-05-29	U-1766	Drug substance	2015-11-18
N205739-001	11123363	2033-10-08	U-1766		2021-09-21
N205739-001	9492476	2033-10-08	U-1766		2016-12-13
N205739-001	9925212	2033-10-08	U-1766		2018-04-20
N205739-002	8216560	2027-03-14	U-1766		2015-11-18
N205739-002	8282913	2027-05-29		Drug product	2015-11-18
N205739-002	8147873	2028-06-20		Drug product	2015-11-18
N205739-002	8337824	2030-05-29	U-1766	Drug substance	2015-11-18
N205739-002	11123363	2033-10-08	U-1766		2021-09-21
N205739-002	9492476	2033-10-08	U-1766		2016-12-13
N205739-002	9925212	2033-10-08	U-1766		2018-04-20
N205739-003	8216560	2027-03-14	U-1766		2015-11-18
N205739-003	8282913	2027-05-29		Drug product	2015-11-18
N205739-003	8147873	2028-06-20		Drug product	2015-11-18
N205739-003	8337824	2030-05-29	U-1766	Drug substance	2015-11-18
N205739-003	11123363	2033-10-08	U-1766		2021-09-21
N205739-003	9492476	2033-10-08	U-1766		2016-12-13
N205739-003	9925212	2033-10-08	U-1766		2018-04-20
N205739-004	8216560	2027-03-14	U-1766		2023-10-31
N205739-004	8282913	2027-05-29		Drug product	2023-10-31
N205739-004	8147873	2028-06-20		Drug product	2023-10-31
N205739-004	8337824	2030-05-29	U-1766	Drug substance	2023-10-31
N205739-004	11123363	2033-10-08	U-1766		2023-10-31
N205739-004	9492476	2033-10-08	U-1766		2023-10-31
N205739-004	9925212	2033-10-08	U-1766		2023-10-31

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N205739-001	NPP	2026-10-02
N205739-002	NPP	2026-10-02
N205739-003	NPP	2026-10-02
N205739-004	NS	2026-10-02

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 4 · 150 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N205739-001	VELTASSA	EQ 8.4GM BASE/PACKET	POWDER / ORAL	RLD	2015-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-002	VELTASSA	EQ 16.8GM BASE/PACKET	POWDER / ORAL	RLD, RS	2015-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-003	VELTASSA	EQ 25.2GM BASE/PACKET	POWDER / ORAL	RLD	2015-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-004	VELTASSA	EQ 1GM BASE/PACKET	POWDER / ORAL	RLD	2023-10-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205739-001	VELTASSA	EQ 8.4GM BASE/PACKET	POWDER / ORAL	RLD	2015-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205739-002	VELTASSA	EQ 16.8GM BASE/PACKET	POWDER / ORAL	RLD, RS	2015-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205739-003	VELTASSA	EQ 25.2GM BASE/PACKET	POWDER / ORAL	RLD	2015-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205739-004	VELTASSA	EQ 1GM BASE/PACKET	POWDER / ORAL	RLD	2023-10-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205739-001	VELTASSA	EQ 8.4GM BASE/PACKET	POWDER / ORAL	RLD	2015-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205739-002	VELTASSA	EQ 16.8GM BASE/PACKET	POWDER / ORAL	RLD, RS	2015-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205739-003	VELTASSA	EQ 25.2GM BASE/PACKET	POWDER / ORAL	RLD	2015-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205739-004	VELTASSA	EQ 1GM BASE/PACKET	POWDER / ORAL	RLD	2023-10-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205739-001	VELTASSA	EQ 8.4GM BASE/PACKET	POWDER / ORAL	RLD	2015-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205739-002	VELTASSA	EQ 16.8GM BASE/PACKET	POWDER / ORAL	RLD, RS	2015-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205739-003	VELTASSA	EQ 25.2GM BASE/PACKET	POWDER / ORAL	RLD	2015-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205739-004	VELTASSA	EQ 1GM BASE/PACKET	POWDER / ORAL	RLD	2023-10-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205739-001	VELTASSA	EQ 8.4GM BASE/PACKET	POWDER / ORAL	RLD	2015-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205739-002	VELTASSA	EQ 16.8GM BASE/PACKET	POWDER / ORAL	RLD, RS	2015-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205739-003	VELTASSA	EQ 25.2GM BASE/PACKET	POWDER / ORAL	RLD	2015-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205739-004	VELTASSA	EQ 1GM BASE/PACKET	POWDER / ORAL	RLD	2023-10-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205739-001	VELTASSA	EQ 8.4GM BASE/PACKET	POWDER / ORAL	RLD	2015-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205739-002	VELTASSA	EQ 16.8GM BASE/PACKET	POWDER / ORAL	RLD, RS	2015-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205739-003	VELTASSA	EQ 25.2GM BASE/PACKET	POWDER / ORAL	RLD	2015-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205739-004	VELTASSA	EQ 1GM BASE/PACKET	POWDER / ORAL	RLD	2023-10-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205739-001	VELTASSA	EQ 8.4GM BASE/PACKET	POWDER / ORAL	RLD	2015-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205739-002	VELTASSA	EQ 16.8GM BASE/PACKET	POWDER / ORAL	RLD, RS	2015-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205739-003	VELTASSA	EQ 25.2GM BASE/PACKET	POWDER / ORAL	RLD	2015-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205739-004	VELTASSA	EQ 1GM BASE/PACKET	POWDER / ORAL	RLD	2023-10-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205739-001	VELTASSA	EQ 8.4GM BASE/PACKET	POWDER / ORAL	RLD	2015-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205739-002	VELTASSA	EQ 16.8GM BASE/PACKET	POWDER / ORAL	RLD, RS	2015-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205739-003	VELTASSA	EQ 25.2GM BASE/PACKET	POWDER / ORAL	RLD	2015-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205739-004	VELTASSA	EQ 1GM BASE/PACKET	POWDER / ORAL	RLD	2023-10-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205739-001	VELTASSA	EQ 8.4GM BASE/PACKET	POWDER / ORAL	RLD	2015-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205739-002	VELTASSA	EQ 16.8GM BASE/PACKET	POWDER / ORAL	RLD, RS	2015-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205739-003	VELTASSA	EQ 25.2GM BASE/PACKET	POWDER / ORAL	RLD	2015-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205739-004	VELTASSA	EQ 1GM BASE/PACKET	POWDER / ORAL	RLD	2023-10-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205739-001	VELTASSA	EQ 8.4GM BASE/PACKET	POWDER / ORAL	RLD	2015-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205739-002	VELTASSA	EQ 16.8GM BASE/PACKET	POWDER / ORAL	RLD, RS	2015-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205739-003	VELTASSA	EQ 25.2GM BASE/PACKET	POWDER / ORAL	RLD	2015-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205739-004	VELTASSA	EQ 1GM BASE/PACKET	POWDER / ORAL	RLD	2023-10-02	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 44 · 1,725 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	N205739-001	8216560	2027-03-14	U-1766		2015-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-001	8282913	2027-05-29		Drug product	2015-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-001	8147873	2028-06-20		Drug product	2015-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-001	8337824	2030-05-29	U-1766	Drug substance	2015-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-001	11123363	2033-10-08	U-1766		2021-09-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-001	9492476	2033-10-08	U-1766		2016-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-001	9925212	2033-10-08	U-1766		2018-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-002	8216560	2027-03-14	U-1766		2015-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-002	8282913	2027-05-29		Drug product	2015-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-002	8147873	2028-06-20		Drug product	2015-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-002	8337824	2030-05-29	U-1766	Drug substance	2015-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-002	11123363	2033-10-08	U-1766		2021-09-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-002	9492476	2033-10-08	U-1766		2016-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-002	9925212	2033-10-08	U-1766		2018-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-003	8216560	2027-03-14	U-1766		2015-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-003	8282913	2027-05-29		Drug product	2015-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-003	8147873	2028-06-20		Drug product	2015-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-003	8337824	2030-05-29	U-1766	Drug substance	2015-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-003	11123363	2033-10-08	U-1766		2021-09-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-003	9492476	2033-10-08	U-1766		2016-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-003	9925212	2033-10-08	U-1766		2018-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-004	8216560	2027-03-14	U-1766		2023-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-004	8282913	2027-05-29		Drug product	2023-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-004	8147873	2028-06-20		Drug product	2023-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-004	8337824	2030-05-29	U-1766	Drug substance	2023-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-004	11123363	2033-10-08	U-1766		2023-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-004	9492476	2033-10-08	U-1766		2023-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-004	9925212	2033-10-08	U-1766		2023-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205739-001	8216560	2027-03-14	U-1766		2015-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205739-001	8282913	2027-05-29		Drug product	2015-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205739-001	8147873	2028-06-20		Drug product	2015-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205739-001	8337824	2030-05-29	U-1766	Drug substance	2015-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205739-001	11123363	2033-10-08	U-1766		2021-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205739-001	9492476	2033-10-08	U-1766		2016-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205739-001	9925212	2033-10-08	U-1766		2018-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205739-002	8216560	2027-03-14	U-1766		2015-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205739-002	8282913	2027-05-29		Drug product	2015-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205739-002	8147873	2028-06-20		Drug product	2015-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205739-002	8337824	2030-05-29	U-1766	Drug substance	2015-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205739-002	11123363	2033-10-08	U-1766		2021-09-21	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 98 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	N205739-001	NPP	2026-10-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-002	NPP	2026-10-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-003	NPP	2026-10-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205739-004	NS	2026-10-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205739-001	NPP	2026-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205739-002	NPP	2026-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205739-003	NPP	2026-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205739-004	NS	2026-10-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205739-001	NPP	2026-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205739-002	NPP	2026-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205739-003	NPP	2026-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205739-004	NS	2026-10-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205739-001	NPP	2026-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205739-002	NPP	2026-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205739-003	NPP	2026-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205739-004	NS	2026-10-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205739-001	NPP	2026-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205739-002	NPP	2026-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205739-003	NPP	2026-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205739-004	NS	2026-10-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205739-001	NPP	2026-10-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205739-002	NPP	2026-10-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205739-003	NPP	2026-10-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205739-004	NS	2026-10-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205739-001	NPP	2026-10-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205739-002	NPP	2026-10-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205739-003	NPP	2026-10-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205739-004	NS	2026-10-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205739-001	NPP	2026-10-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205739-002	NPP	2026-10-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205739-003	NPP	2026-10-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205739-004	NS	2026-10-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205739-001	NPP	2026-10-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205739-002	NPP	2026-10-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205739-003	NPP	2026-10-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205739-004	NS	2026-10-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205739-001	NPP	2026-10-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205739-002	NPP	2026-10-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205739-003	NPP	2026-10-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205739-004	NS	2026-10-02	`5bbf6a4d5a75…`

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: VELTASSA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PATIROMER	16.8 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1FQ2RY5YHH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1716209	Internal RxNorm lookup
1716215	Internal RxNorm lookup
1716217	Internal RxNorm lookup
1716219	Internal RxNorm lookup
1716221	Internal RxNorm lookup
1716223	Internal RxNorm lookup
2692050	Internal RxNorm lookup
2692052	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
bf002984-d6c9-46df-aecb-a07733f763c1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4ba40eb-1b5c-4d96-9a06-8ded1ce02126	Product name	2	20250625

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53436-168-30	2024-08-15	C162847	48780-1	1030e365-0a48-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use VELTASSA ® safely and effectively. See full prescribing information for VELTASSA. VELTASSA (patiromer) for oral suspension Initial U.S. Approval: 2015
53436-168-30	2024-07-30	C162847	48780-1	1030e365-0a48-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use VELTASSA ® safely and effectively. See full prescribing information for VELTASSA. VELTASSA (patiromer) for oral suspension Initial U.S. Approval: 2015
53436-168-30	2024-01-30	C162847	48780-1	1030e365-0a48-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use VELTASSA ® safely and effectively. See full prescribing information for VELTASSA. VELTASSA (patiromer) for oral suspension Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53436-168-01	VELTASSA	1 in 1 PACKET	POWDER, FOR SUSPENSION	1		23
53436-168-30	VELTASSA	30 in 1 CARTON	POWDER, FOR SUSPENSION	30		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53436-168-01	EA - Each	53436-168	7b9b084d-8df9-4f09-8c04-4d33d90dcbb3	1	2015-12-02
53436-168-30	EA - Each	53436-168	91f3acf5-3c74-4b4f-b2c1-8fa91211425c	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
patiromer	ACTIVE INGREDIENT	1FQ2RY5YHH	VELTASSA (PATIROMER) POWDER, FOR SUSPENSION [RELYPSA, INC.]	4
patiromer	ACTIVE MOIETY	1FQ2RY5YHH	VELTASSA (PATIROMER) POWDER, FOR SUSPENSION [RELYPSA, INC.]	4
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	VELTASSA (PATIROMER) POWDER, FOR SUSPENSION [RELYPSA, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53436-168	VELTASSA (PATIROMER) POWDER, FOR SUSPENSION [VIFOR PHARMA, INC.]	23	Current NDC, Legacy NDC, 2 package rows	20250209_bf002984-d6c9-46df-aecb-a07733f763c1.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
VELTASSA	PATIROMER	Vifor Pharma, Inc.	bf002984-d6c9-46df-aecb-a07733f763c1	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205739 application number: NDA205739 ndc (product): 53436-168

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1FQ2RY5YHH	PATIROMER	1260643-52-4	PATIROMER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2692050	patiromer 1 GM Powder for Oral Suspension	PSN	bf002984-d6c9-46df-aecb-a07733f763c1	23
1716217	patiromer 16.8 GM Powder for Oral Suspension	PSN	bf002984-d6c9-46df-aecb-a07733f763c1	23
1716221	patiromer 25.2 GM Powder for Oral Suspension	PSN	bf002984-d6c9-46df-aecb-a07733f763c1	23
1716209	patiromer 8.4 GM Powder for Oral Suspension	PSN	bf002984-d6c9-46df-aecb-a07733f763c1	23
2692052	Veltassa 1 GM Powder for Oral Suspension	PSN	bf002984-d6c9-46df-aecb-a07733f763c1	23
1716219	Veltassa 16.8 GM Powder for Oral Suspension	PSN	bf002984-d6c9-46df-aecb-a07733f763c1	23
1716223	Veltassa 25.2 GM Powder for Oral Suspension	PSN	bf002984-d6c9-46df-aecb-a07733f763c1	23
1716215	Veltassa 8.4 GM Powder for Oral Suspension	PSN	bf002984-d6c9-46df-aecb-a07733f763c1	23
2692052	patiromer 1000 MG Powder for Oral Suspension [Veltassa]	SBD	bf002984-d6c9-46df-aecb-a07733f763c1	23
1716219	patiromer 16800 MG Powder for Oral Suspension [Veltassa]	SBD	bf002984-d6c9-46df-aecb-a07733f763c1	23
1716223	patiromer 25200 MG Powder for Oral Suspension [Veltassa]	SBD	bf002984-d6c9-46df-aecb-a07733f763c1	23
1716215	patiromer 8400 MG Powder for Oral Suspension [Veltassa]	SBD	bf002984-d6c9-46df-aecb-a07733f763c1	23
2692050	patiromer 1000 MG Powder for Oral Suspension	SCD	bf002984-d6c9-46df-aecb-a07733f763c1	23
1716217	patiromer 16800 MG Powder for Oral Suspension	SCD	bf002984-d6c9-46df-aecb-a07733f763c1	23
1716221	patiromer 25200 MG Powder for Oral Suspension	SCD	bf002984-d6c9-46df-aecb-a07733f763c1	23
1716209	patiromer 8400 MG Powder for Oral Suspension	SCD	bf002984-d6c9-46df-aecb-a07733f763c1	23
2692050	patiromer 1 GM Powder for Oral Suspension	SY	bf002984-d6c9-46df-aecb-a07733f763c1	23
1716217	patiromer 16.8 GM Powder for Oral Suspension	SY	bf002984-d6c9-46df-aecb-a07733f763c1	23
1716221	patiromer 25.2 GM Powder for Oral Suspension	SY	bf002984-d6c9-46df-aecb-a07733f763c1	23
1716209	patiromer 8.4 GM Powder for Oral Suspension	SY	bf002984-d6c9-46df-aecb-a07733f763c1	23
2692052	Veltassa 1 GM Powder for Oral Suspension	SY	bf002984-d6c9-46df-aecb-a07733f763c1	23
2692052	Veltassa 1000 MG Powder for Oral Suspension	SY	bf002984-d6c9-46df-aecb-a07733f763c1	23
1716219	Veltassa 16.8 GM Powder for Oral Suspension	SY	bf002984-d6c9-46df-aecb-a07733f763c1	23
1716219	Veltassa 16800 MG Powder for Oral Suspension	SY	bf002984-d6c9-46df-aecb-a07733f763c1	23
1716223	Veltassa 25.2 GM Powder for Oral Suspension	SY	bf002984-d6c9-46df-aecb-a07733f763c1	23
1716223	Veltassa 25200 MG Powder for Oral Suspension	SY	bf002984-d6c9-46df-aecb-a07733f763c1	23
1716215	Veltassa 8.4 GM Powder for Oral Suspension	SY	bf002984-d6c9-46df-aecb-a07733f763c1	23
1716215	Veltassa 8400 MG Powder for Oral Suspension	SY	bf002984-d6c9-46df-aecb-a07733f763c1	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53436-168-01	53436016801	1 in 1 PACKET						Historical
53436-168-30	53436016830	30 PACKET in 1 CARTON (53436-168-30) / 1 POWDER, FOR SUSPENSION in 1 PACKET (53436-168-01)	30 packet	2015-10-23	0000-00-00	No	No	Current