Home NDC 71770-200 PHEBURANE
Product NDC 71770-200
11-digit product format 717700200
Labeler code 71770
Product ID 71770-200_4072f3df-e754-4c2e-be0c-af3c8edb9211
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium phenylbutyrate
Dosage form KIT
Labeler Medunik USA
Application NDA216513
Marketing category NDA
Marketing start 2022-08-26
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 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…
Additional Listing Data#
Finished product Yes
Brand name base PHEBURANE
Listing expiration 2027-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2610128 Internal RxNorm lookup 2610134 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 71770-200-10 PHEBURANE 1 in 1 CARTON KIT 1 6 71770-210-10 PHEBURANE 174 g in 1 BOTTLE PELLET 174 g 483 mg in 1g 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71770-200 PHEBURANE (SODIUM PHENYLBUTYRATE) PELLET PHEBURANE (SODIUM PHENYLBUTYRATE) KIT [MEDUNIK USA] 5 Current NDC, Legacy NDC, 2 package rows 20241222_d15f2cbf-4d22-40b5-8ef9-16b9d323a7f9.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.
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 71770-200-10 71770020010 1 KIT in 1 CARTON (71770-200-10) * 174 g in 1 BOTTLE (71770-210-10) 1 kit 2022-08-26 0000-00-00 No No Current 71770-210-10 71770021010 174 g in 1 BOTTLE 174 g Historical