PROCYSBI

Product NDC: 75987-100
11-digit product format: 759870100
Labeler code: 75987
Product ID: 75987-100_374233b1-345c-4d9e-9bc0-e5aa2f9d8e1f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cysteamine bitartrate
Dosage form: CAPSULE, DELAYED RELEASE PELLETS
Route: ORAL
Labeler: Horizon Therapeutics USA, Inc.
Application: NDA203389
Marketing category: NDA
Marketing start: 2013-04-30
Substance: CYSTEAMINE BITARTRATE
Active strength: 25 mg/1
Pharmacologic classes: Cystine Depleting Agent [EPC], Cystine Disulfide Reduction [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 1.

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
N203389-001	PROCYSBI	CYSTEAMINE BITARTRATE	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL		RLD	2013-04-30
N203389-002	PROCYSBI	CYSTEAMINE BITARTRATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2013-04-30

Orange Book patents#

Current patent rows page 1 of 1 · 48 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203389-001	9192590	2027-01-26	U-1399		2015-11-25
N203389-001	9198882	2027-01-26	U-1399		2015-12-02
N203389-001	9925156	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19
N203389-001	9925157	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19
N203389-001	9925158	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19
N203389-001	9192590*PED	2027-07-26		Pediatric extension
N203389-001	9198882*PED	2027-07-26		Pediatric extension
N203389-001	9925156*PED	2027-07-26		Pediatric extension
N203389-001	9925157*PED	2027-07-26		Pediatric extension
N203389-001	9925158*PED	2027-07-26		Pediatric extension
N203389-001	8026284	2027-09-22	U-1399		2013-05-24
N203389-001	8026284*PED	2028-03-22		Pediatric extension
N203389-001	9173851	2034-06-17		Drug product	2015-11-04
N203389-001	9233077	2034-06-17		Drug product	2016-01-13
N203389-001	9173851*PED	2034-12-17		Pediatric extension
N203389-001	9233077*PED	2034-12-17		Pediatric extension
N203389-001	10143665	2036-08-16	U-1399		2018-12-20
N203389-001	10328037	2036-08-16	U-1399		2019-07-25
N203389-001	10548859	2036-08-16	U-1399		2020-03-04
N203389-001	10905662	2036-08-16	U-1399		2021-03-02
N203389-001	10143665*PED	2037-02-16		Pediatric extension
N203389-001	10328037*PED	2037-02-16		Pediatric extension
N203389-001	10548859*PED	2037-02-16		Pediatric extension
N203389-001	10905662*PED	2037-02-16		Pediatric extension
N203389-002	9192590	2027-01-26	U-1399		2015-11-25
N203389-002	9198882	2027-01-26	U-1399		2015-12-02
N203389-002	9925156	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19
N203389-002	9925157	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19
N203389-002	9925158	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19
N203389-002	9192590*PED	2027-07-26		Pediatric extension
N203389-002	9198882*PED	2027-07-26		Pediatric extension
N203389-002	9925156*PED	2027-07-26		Pediatric extension
N203389-002	9925157*PED	2027-07-26		Pediatric extension
N203389-002	9925158*PED	2027-07-26		Pediatric extension
N203389-002	8026284	2027-09-22	U-1399
N203389-002	8026284*PED	2028-03-22		Pediatric extension
N203389-002	9173851	2034-06-17		Drug product	2015-11-04
N203389-002	9233077	2034-06-17		Drug product	2016-01-13
N203389-002	9173851*PED	2034-12-17		Pediatric extension
N203389-002	9233077*PED	2034-12-17		Pediatric extension
N203389-002	10143665	2036-08-16	U-1399		2018-12-20
N203389-002	10328037	2036-08-16	U-1399		2019-07-25
N203389-002	10548859	2036-08-16	U-1399		2020-03-04
N203389-002	10905662	2036-08-16	U-1399		2021-03-02
N203389-002	10143665*PED	2037-02-16		Pediatric extension
N203389-002	10328037*PED	2037-02-16		Pediatric extension
N203389-002	10548859*PED	2037-02-16		Pediatric extension
N203389-002	10905662*PED	2037-02-16		Pediatric extension

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 · 82 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	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203389-001	PROCYSBI	EQ 25MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-04-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203389-002	PROCYSBI	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-04-30	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 44 · 1,748 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	N203389-001	9192590	2027-01-26	U-1399		2015-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-001	9198882	2027-01-26	U-1399		2015-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-001	9925156	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-001	9925157	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-001	9925158	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-001	9192590*PED	2027-07-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-001	9198882*PED	2027-07-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-001	9925156*PED	2027-07-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-001	9925157*PED	2027-07-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-001	9925158*PED	2027-07-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-001	8026284	2027-09-22	U-1399		2013-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-001	8026284*PED	2028-03-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-001	9173851	2034-06-17		Drug product	2015-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-001	9233077	2034-06-17		Drug product	2016-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-001	9173851*PED	2034-12-17		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-001	9233077*PED	2034-12-17		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-001	10143665	2036-08-16	U-1399		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-001	10328037	2036-08-16	U-1399		2019-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-001	10548859	2036-08-16	U-1399		2020-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-001	10905662	2036-08-16	U-1399		2021-03-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-001	10143665*PED	2037-02-16		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-001	10328037*PED	2037-02-16		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-001	10548859*PED	2037-02-16		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-001	10905662*PED	2037-02-16		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-002	9192590	2027-01-26	U-1399		2015-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-002	9198882	2027-01-26	U-1399		2015-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-002	9925156	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-002	9925157	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-002	9925158	2027-01-26	U-1399	Drug substance, Drug product	2018-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-002	9192590*PED	2027-07-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-002	9198882*PED	2027-07-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-002	9925156*PED	2027-07-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-002	9925157*PED	2027-07-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-002	9925158*PED	2027-07-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-002	8026284	2027-09-22	U-1399			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-002	8026284*PED	2028-03-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-002	9173851	2034-06-17		Drug product	2015-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-002	9233077	2034-06-17		Drug product	2016-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-002	9173851*PED	2034-12-17		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203389-002	9233077*PED	2034-12-17		Pediatric extension		`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 7 · 266 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203389-001	ODE-162	2024-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203389-001	PED	2025-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203389-002	ODE-162	2024-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203389-002	PED	2025-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203389-001	ODE-162	2024-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203389-001	PED	2025-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203389-002	ODE-162	2024-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203389-002	PED	2025-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203389-001	ODE-162	2024-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203389-001	PED	2025-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203389-002	ODE-162	2024-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203389-002	PED	2025-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203389-001	ODE-162	2024-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203389-001	PED	2025-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203389-002	ODE-162	2024-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203389-002	PED	2025-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203389-001	ODE-162	2024-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203389-001	PED	2025-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203389-002	ODE-162	2024-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203389-002	PED	2025-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203389-001	ODE-162	2024-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203389-001	PED	2025-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203389-002	ODE-162	2024-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203389-002	PED	2025-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203389-001	ODE-162	2024-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203389-001	PED	2025-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203389-002	ODE-162	2024-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203389-002	PED	2025-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203389-001	ODE-162	2024-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203389-001	PED	2025-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203389-002	ODE-162	2024-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203389-002	PED	2025-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203389-001	ODE-162	2024-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203389-001	PED	2025-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203389-002	ODE-162	2024-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203389-002	PED	2025-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203389-001	ODE-162	2024-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203389-001	PED	2025-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203389-002	ODE-162	2024-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203389-002	PED	2025-06-22	`79d66fd596c7…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CYSTEAMINE BITARTRATE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
QO84GZ3TST	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1421467	Internal RxNorm lookup
1421473	Internal RxNorm lookup
1421475	Internal RxNorm lookup
1421477	Internal RxNorm lookup
2284510	Internal RxNorm lookup
2284514	Internal RxNorm lookup
2284515	Internal RxNorm lookup
2284516	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
d3a3ec28-f746-463a-bb92-3bc8826db09e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dd012da9-cd07-4d66-b6f1-ce3bdc2a3665	Product name	1	20210312
3d59dc1e-80a4-4b1f-b3e1-387c65c31efb	Product name	3	20200619
a4fffefe-232a-3e06-c77d-1e6fdaec7d5e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
75987-100-04	PROCYSBI	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE PELLETS	60		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
75987-100-04	EA - Each	75987-100	15640ef3-4d9b-4832-b754-26ed2546364e	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75987-100	PROCYSBI (CYSTEAMINE BITARTRATE) CAPSULE, DELAYED RELEASE PELLETS PROCYSBI (CYSTEAMINE BITARTRATE) GRANULE, DELAYED RELEASE [HORIZON THERAPEUTICS USA, INC.]	12	Current NDC, Legacy NDC, 1 package rows	20250423_d3a3ec28-f746-463a-bb92-3bc8826db09e.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
PROCYSBI	CYSTEAMINE BITARTRATE	Horizon Therapeutics USA, Inc.	d3a3ec28-f746-463a-bb92-3bc8826db09e	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203389 application number: NDA203389 ndc (product): 75987-100

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QO84GZ3TST	CYSTEAMINE BITARTRATE	27761-19-9	CYSTEAMINE BITARTRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1421467	cysteamine 25 MG Delayed Release Oral Capsule	PSN	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
2284510	cysteamine 300 MG Delayed Release Oral Granules	PSN	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
1421475	cysteamine 75 MG Delayed Release Oral Capsule	PSN	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
2284515	cysteamine 75 MG Delayed Release Oral Granules	PSN	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
1421473	PROCYSBI 25 MG Delayed Release Oral Capsule	PSN	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
2284514	PROCYSBI 300 MG Delayed Release Oral Granules	PSN	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
1421477	PROCYSBI 75 MG Delayed Release Oral Capsule	PSN	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
2284516	PROCYSBI 75 MG Delayed Release Oral Granules	PSN	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
1421473	cysteamine 25 MG Delayed Release Oral Capsule [Procysbi]	SBD	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
2284514	cysteamine 300 MG Delayed Release Oral Granules [Procysbi]	SBD	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
1421477	cysteamine 75 MG Delayed Release Oral Capsule [Procysbi]	SBD	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
2284516	cysteamine 75 MG Delayed Release Oral Granules [Procysbi]	SBD	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
1421467	cysteamine 25 MG Delayed Release Oral Capsule	SCD	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
2284510	cysteamine 300 MG Delayed Release Oral Granules	SCD	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
1421475	cysteamine 75 MG Delayed Release Oral Capsule	SCD	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
2284515	cysteamine 75 MG Delayed Release Oral Granules	SCD	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
2284510	cysteamin (as cysteamine bitartrate) 300 MG Delayed Release Oral Granules	SY	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
2284515	cysteamine (as cysteamine bitartrate) 75 MG Delayed Release Oral Granules	SY	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
1421467	cysteamine 25 MG (as cysteamine bitartrate 74 mg) Delayed Release Oral Capsule	SY	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
1421475	cysteamine 75 MG (as cysteamine bitartrate 221 MG) Delayed Release Oral Capsule	SY	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
1421473	Procysbi (cysteamine 25 MG (as cysteamine bitartrate 74 MG)) Delayed Release Oral Capsule	SY	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
1421477	Procysbi (cysteamine 75 MG (as cysteamine bitartrate 221 MG)) Delayed Release Oral Capsule	SY	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
1421473	Procysbi 25 MG Delayed Release Oral Capsule	SY	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
2284514	Procysbi 300 MG Delayed Release Oral Granules	SY	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
1421477	Procysbi 75 MG Delayed Release Oral Capsule	SY	d3a3ec28-f746-463a-bb92-3bc8826db09e	12
2284516	Procysbi 75 MG Delayed Release Oral Granules	SY	d3a3ec28-f746-463a-bb92-3bc8826db09e	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
75987-100-04	75987010004	60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (75987-100-04)	2013-04-30	0000-00-00	No	No	Current