Home NDC 71770-100-10 PHEBURANE
Product NDC 71770-100
Requested package NDC 71770-100-10
11-digit product format 717700100
Labeler code 71770
Product ID 71770-100_5c309e18-6001-4bd1-93ae-17be10c3dad4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium phenylbutyrate
Dosage form PELLET
Route ORAL
Labeler Medunik USA
Application NDA216513
Marketing category NDA
Marketing start 2022-08-26
Marketing end 0000-00-00
Substance SODIUM PHENYLBUTYRATE
Active strength 483 mg/g
Pharmacologic classes Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 N216513-001 PHEBURANE SODIUM PHENYLBUTYRATE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17
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 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216513-001 PHEBURANE 84GM/BOT PELLETS / ORAL RLD, RS 2022-06-17 a50c72e98297…
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 PHEBURANE SODIUM PHENYLBUTYRATE Medunik USA d15f2cbf-4d22-40b5-8ef9-16b9d323a7f9 2026-07-17 Warnings, Adverse reactions Exact identifier application applno (NDA): 216513 application number: NDA216513
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71770-100-10 71770010010 174 g in 1 BOTTLE (71770-100-10) 174 g 2022-08-26 0000-00-00 No No Current