Home NDC 70748-425 glycerol phenylbutyrate
Product NDC 70748-425
11-digit product format 707480425
Labeler code 70748
Product ID 70748-425_fd8b7042-85e8-4193-8ce3-2d4ca69d6371
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name glycerol phenylbutyrate
Dosage form LIQUID
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application NDA203284
Marketing category NDA
Marketing start 2025-10-20
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 1 .
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.
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 · 41 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 2026-02-19 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…2022-09-29 23:25 UTC 2022-09 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N203284-001 RAVICTI 1.1GM/ML LIQUID / ORAL RLD, RS 2013-02-01 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 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 16 · 634 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 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…2026-02-19 14:30 UTC 2026-02 N203284-001 9962359 2030-09-22 U-1816 2018-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203284-001 9999608 2030-09-22 U-1816 2018-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203284-001 8404215 2032-03-09 U-1383 Delist requested 2013-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 10045958 2030-09-22 U-1816 2018-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 10045959 2030-09-22 U-1816 2018-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 10183002 2030-09-22 U-1816 2019-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 10183003 2030-09-22 U-1816 2019-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 10183004 2030-09-22 U-1816 2019-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 10183005 2030-09-22 U-1816 2019-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 10183006 2030-09-22 U-1816 2019-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 10668040 2030-09-22 U-1816 2020-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 8642012 2030-09-22 U-1383 2014-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 9254278 2030-09-22 U-1816 2016-02-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 9326966 2030-09-22 U-1816 2016-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 9561197 2030-09-22 U-1383 2017-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 9962359 2030-09-22 U-1816 2018-06-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 9999608 2030-09-22 U-1816 2018-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203284-001 8404215 2032-03-09 U-1383 Delist requested 2013-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203284-001 10045958 2030-09-22 U-1816 2018-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203284-001 10045959 2030-09-22 U-1816 2018-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203284-001 10183002 2030-09-22 U-1816 2019-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203284-001 10183003 2030-09-22 U-1816 2019-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203284-001 10183004 2030-09-22 U-1816 2019-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203284-001 10183005 2030-09-22 U-1816 2019-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203284-001 10183006 2030-09-22 U-1816 2019-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203284-001 10668040 2030-09-22 U-1816 2020-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203284-001 8642012 2030-09-22 U-1383 2014-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203284-001 9254278 2030-09-22 U-1816 2016-02-29 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 48 observed states.
Additional Listing Data#
Finished product Yes
Brand name base glycerol phenylbutyrate
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1368453 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70748-425-01 glycerol phenylbutyrate 25 mL in 1 BOTTLE LIQUID 25 1 70748-425-01 glycerol phenylbutyrate 1 in 1 CARTON LIQUID 1 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70748-425-01 70748042501 1 BOTTLE in 1 CARTON (70748-425-01) / 25 mL in 1 BOTTLE 1 bottle 2025-10-20 No No Current