Home NDC 75987-070 Buphenyl
Product NDC 75987-070
11-digit product format 759870070
Labeler code 75987
Product ID 75987-070_3178e0bc-ebb7-4ddd-be43-630ff87eeb02
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sodium phenylbutyrate
Dosage form POWDER
Route ORAL
Labeler Horizon Therapeutics USA, Inc.
Application NDA020573
Marketing category NDA
Marketing start 1996-04-30
Substance SODIUM PHENYLBUTYRATE
Active strength .94 g/g
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 N020573-001 BUPHENYL SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL RLD 1996-04-30
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 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL RLD 1996-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020573-001 BUPHENYL 3GM/TEASPOONFUL POWDER / ORAL AB RLD, RS 1996-04-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Buphenyl
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM PHENYLBUTYRATE .94 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination NT6K61736T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199369 Internal RxNorm lookup 213196 Internal RxNorm lookup 984105 Internal RxNorm lookup 984107 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 75987-070-09 Buphenyl 1 in 1 CARTON POWDER 1 9 75987-070-09 Buphenyl 250 g in 1 BOTTLE POWDER 250 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75987-070 BUPHENYL (SODIUM PHENYLBUTYRATE) TABLET BUPHENYL (SODIUM PHENYLBUTYRATE) POWDER [HORIZON THERAPEUTICS USA, INC.] 9 Current NDC, Legacy NDC, 2 package rows 20241114_463a36fa-3eb2-4326-8bd0-c8c7a11bca3a.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 BUPHENYL SODIUM PHENYLBUTYRATE Horizon Therapeutics USA, Inc. 463a36fa-3eb2-4326-8bd0-c8c7a11bca3a 2024-10-30 Warnings, Adverse reactions Exact identifier application applno (NDA): 020573 application number: NDA020573 ndc (product): 75987-070
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 75987-070-09 75987007009 1 BOTTLE in 1 CARTON (75987-070-09) / 250 g in 1 BOTTLE 1 bottle 1996-04-30 0000-00-00 No No Current