Ravicti

Product NDC: 75987-050
11-digit product format: 759870050
Labeler code: 75987
Product ID: 75987-050_a58b617c-635a-4a67-9f27-f9c93f8cba22
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: glycerol phenylbutyrate
Dosage form: LIQUID
Route: ORAL
Labeler: Horizon Therapeutics USA, Inc.
Application: NDA203284
Marketing category: NDA
Marketing start: 2013-02-28
Substance: GLYCEROL PHENYLBUTYRATE
Active strength: 1.1 g/mL
Pharmacologic classes: Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203284-001	RAVICTI	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL	AA	RLD, RS	2013-02-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N203284-001	AA

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N203284-001	10045958	2030-09-22	U-1816	2018-08-22
N203284-001	10045959	2030-09-22	U-1816	2018-08-22
N203284-001	10183002	2030-09-22	U-1816	2019-02-21
N203284-001	10183003	2030-09-22	U-1816	2019-02-21
N203284-001	10183004	2030-09-22	U-1816	2019-02-21
N203284-001	10183005	2030-09-22	U-1816	2019-02-21
N203284-001	10183006	2030-09-22	U-1816	2019-02-21
N203284-001	10668040	2030-09-22	U-1816	2020-07-02
N203284-001	8642012	2030-09-22	U-1383	2014-02-27
N203284-001	9254278	2030-09-22	U-1816	2016-02-29
N203284-001	9326966	2030-09-22	U-1816	2016-05-25
N203284-001	9561197	2030-09-22	U-1383	2017-07-06
N203284-001	9962359	2030-09-22	U-1816	2018-06-07
N203284-001	9999608	2030-09-22	U-1816	2018-07-12

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL	AA	RLD, RS	2013-02-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL	AA	RLD, RS	2013-02-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL	AA	RLD, RS	2013-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL	AA	RLD, RS	2013-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL	AA	RLD, RS	2013-02-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N203284-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203284-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203284-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203284-001	AA	1	`31067a03dcf5…`
2021-12-28 21:50 UTC	2021-12	N203284-001	AA	1	`782e0a99824c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203284-001	AA	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 17 · 662 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N203284-001	10045958	2030-09-22	U-1816	2018-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	10045959	2030-09-22	U-1816	2018-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	10183002	2030-09-22	U-1816	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	10183003	2030-09-22	U-1816	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	10183004	2030-09-22	U-1816	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	10183005	2030-09-22	U-1816	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	10183006	2030-09-22	U-1816	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	10668040	2030-09-22	U-1816	2020-07-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	8642012	2030-09-22	U-1383	2014-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	9254278	2030-09-22	U-1816	2016-02-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	9326966	2030-09-22	U-1816	2016-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	9561197	2030-09-22	U-1383	2017-07-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	9962359	2030-09-22	U-1816	2018-06-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	9999608	2030-09-22	U-1816	2018-07-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203284-001	10045958	2030-09-22	U-1816	2018-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	10045959	2030-09-22	U-1816	2018-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	10183002	2030-09-22	U-1816	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	10183003	2030-09-22	U-1816	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	10183004	2030-09-22	U-1816	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	10183005	2030-09-22	U-1816	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	10183006	2030-09-22	U-1816	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	10668040	2030-09-22	U-1816	2020-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	8642012	2030-09-22	U-1383	2014-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	9254278	2030-09-22	U-1816	2016-02-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	9326966	2030-09-22	U-1816	2016-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	9561197	2030-09-22	U-1383	2017-07-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	9962359	2030-09-22	U-1816	2018-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	9999608	2030-09-22	U-1816	2018-07-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203284-001	10045958	2030-09-22	U-1816	2018-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203284-001	10045959	2030-09-22	U-1816	2018-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203284-001	10183002	2030-09-22	U-1816	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203284-001	10183003	2030-09-22	U-1816	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203284-001	10183004	2030-09-22	U-1816	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203284-001	10183005	2030-09-22	U-1816	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203284-001	10183006	2030-09-22	U-1816	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203284-001	10668040	2030-09-22	U-1816	2020-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203284-001	8642012	2030-09-22	U-1383	2014-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203284-001	9254278	2030-09-22	U-1816	2016-02-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203284-001	9326966	2030-09-22	U-1816	2016-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203284-001	9561197	2030-09-22	U-1383	2017-07-06	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203284-001	ODE-157	2024-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203284-001	ODE-157	2024-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203284-001	ODE-157	2024-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203284-001	ODE-157	2024-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203284-001	ODE-157	2024-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203284-001	ODE-157	2024-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203284-001	ODE-157	2024-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203284-001	ODE-157	2024-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203284-001	ODE-157	2024-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203284-001	ODE-157	2024-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203284-001	ODE-157	2024-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203284-001	ODE-157	2024-04-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203284-001	ODE-42	2020-02-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203284-001	NPP	2020-04-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203284-001	ODE-157	2024-04-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203284-001	ODE-157	2024-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203284-001	NPP	2021-12-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203284-001	ODE-157	2024-04-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203284-001	ODE-157	2024-04-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203284-001	ODE-157	2024-04-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203284-001	ODE-42	2020-02-01	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203284-001	NPP	2020-04-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203284-001	ODE-157	2024-04-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203284-001	ODE-42	2020-02-01	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N203284-001	NPP	2020-04-28	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N203284-001	ODE-157	2024-04-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203284-001	ODE-42	2020-02-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203284-001	NPP	2020-04-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203284-001	ODE-157	2024-04-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203284-001	ODE-42	2020-02-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203284-001	NPP	2020-04-28	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203284-001	ODE-157	2024-04-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203284-001	ODE-42	2020-02-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203284-001	NPP	2020-04-28	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203284-001	ODE-157	2024-04-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203284-001	ODE-157	2024-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203284-001	ODE-157	2024-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203284-001	ODE-157	2024-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203284-001	ODE-157	2024-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203284-001	ODE-157	2024-04-28	`9b2671bbb829…`

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: Ravicti
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLYCEROL PHENYLBUTYRATE	1.1 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ZH6F1VCV7B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1368453	Internal RxNorm lookup
1368459	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
900e7dc0-9afe-4f50-80de-90567bb78519	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0cc537b1-c2e1-c627-bac5-cebf6929cf73	Product name	3	20240109
5b2d409d-7740-4999-9561-96950a3ff604	Product name	1	20230919
33ad3946-5a41-4c5a-ac56-c03c9275532f	Product name	1	20230313
80e18c01-dd53-4091-b66d-ad9549805dab	Product name	1	20221116
f6fdd4e1-690e-487f-b950-ea9fa2ba47d1	Product name	1	20170711
d43c7982-5d28-8a36-d1c0-93d0f3b1ada4	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
75987-050-06	Ravicti	25 mL in 1 BOTTLE	LIQUID	25	13
75987-050-06	Ravicti	1 in 1 CARTON	LIQUID	1	13
75987-050-07	Ravicti	25 mL in 1 BOTTLE	LIQUID	25	13
75987-050-07	Ravicti	4 in 1 CARTON	LIQUID	4	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
75987-050-06	ML - Milliliter	75987-050	588316b1-3c09-404b-bd09-f3b37c6d26f6	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
GLYCEROL PHENYLBUTYRATE	ACTIVE INGREDIENT	ZH6F1VCV7B	RAVICTI (GLYCEROL PHENYLBUTYRATE) LIQUID [HORIZON PHARMA, INC.]	1
GLYCEROL PHENYLBUTYRATE	ACTIVE MOIETY	ZH6F1VCV7B	RAVICTI (GLYCEROL PHENYLBUTYRATE) LIQUID [HORIZON PHARMA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75987-050	RAVICTI (GLYCEROL PHENYLBUTYRATE) LIQUID [HORIZON THERAPEUTICS USA, INC.]	12	Current NDC, Legacy NDC, 4 package rows	20240509_900e7dc0-9afe-4f50-80de-90567bb78519.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ravicti	GLYCEROL PHENYLBUTYRATE	Horizon Therapeutics USA, Inc.	900e7dc0-9afe-4f50-80de-90567bb78519	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203284 application number: NDA203284 ndc (product): 75987-050
glycerol phenylbutyrate	GLYCEROL PHENYLBUTYRATE	Lupin Pharmaceuticals, Inc.	9bfa912f-c86c-4702-ac99-464c4356d80c	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203284 application number: NDA203284

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZH6F1VCV7B	GLYCEROL PHENYLBUTYRATE	611168-24-2	GLYCEROL PHENYLBUTYRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1368453	glycerol phenylbutyrate 1.1 GM in 1 mL Oral Solution	PSN	900e7dc0-9afe-4f50-80de-90567bb78519	13
1368459	RAVICTI 1.1 GM in 1 mL Oral Solution	PSN	900e7dc0-9afe-4f50-80de-90567bb78519	13
1368459	glycerol phenylbutyrate 1100 MG/ML Oral Solution [Ravicti]	SBD	900e7dc0-9afe-4f50-80de-90567bb78519	13
1368453	glycerol phenylbutyrate 1100 MG/ML Oral Solution	SCD	900e7dc0-9afe-4f50-80de-90567bb78519	13
1368453	glycerol phenylbutyrate 1.1 GM per 1 ML Oral Solution	SY	900e7dc0-9afe-4f50-80de-90567bb78519	13
1368459	Ravicti 1100 MG/ML Oral Solution	SY	900e7dc0-9afe-4f50-80de-90567bb78519	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
75987-050-06	75987005006	1 BOTTLE in 1 CARTON (75987-050-06) / 25 mL in 1 BOTTLE	1 bottle	2013-02-28	0000-00-00	No	No	Current
75987-050-07	75987005007	4 BOTTLE in 1 CARTON (75987-050-07) / 25 mL in 1 BOTTLE	4 bottle	2013-02-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ravicti - Horizon Therapeutics USA, Inc.	Horizon Therapeutics USA, Inc.	2025-10-29	HUMAN PRESCRIPTION DRUG LABEL	13