Home NDC 49884-264 Glycerol Phenylbutyrate
Product NDC 49884-264
11-digit product format 498840264
Labeler code 49884
Product ID 49884-264_88787621-3d7b-4665-9535-9e14d67aba66
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glycerol Phenylbutyrate oral
Dosage form LIQUID
Route ORAL
Labeler Par Health USA, LLC
Application ANDA205742
Marketing category ANDA
Marketing start 2025-10-17
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 A205742-001 GLYCEROL PHENYLBUTYRATE GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL AA 2021-12-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205742-001 AA
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A205742-001 PC 2026-04-15
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.
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 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL AA 2021-12-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL AA 2021-12-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL AA 2021-12-02 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL 2021-12-02 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205742-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL AA 2021-12-02 a50c72e98297…
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 A205742-001 AA 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205742-001 AA 1 31067a03dcf5…2021-12-28 21:50 UTC 2021-12 A205742-001 AA 1 782e0a99824c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205742-001 AA 1 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-02-19 14:30 UTC 2026-02 A205742-001 PC 2026-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205742-001 PC 2026-04-15 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205742-001 PC 2026-04-15 a50c72e98297…
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 49884-264-95 Glycerol Phenylbutyrate 25 mL in 1 BOTTLE LIQUID 25 23 49884-264-95 Glycerol Phenylbutyrate 1 in 1 CARTON LIQUID 1 23
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 49884-264-95 49884026495 1 BOTTLE in 1 CARTON (49884-264-95) / 25 mL in 1 BOTTLE 1 bottle 2025-10-17 No No Current