Home NDC 49884-006 Sodium Phenylbutyrate
Product NDC 49884-006
11-digit product format 498840006
Labeler code 49884
Product ID 49884-006_583e7b91-8e00-4c38-a78f-d8948ea95a20
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Phenylbutyrate
Dosage form POWDER
Route ORAL
Labeler Par Health USA, LLC
Application ANDA203918
Marketing category ANDA
Marketing start 2016-08-31
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 2027-12-31
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 A203918-001 SODIUM PHENYLBUTYRATE SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL RS 2016-06-15
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.
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 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB RS 2016-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203918-001 SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER / ORAL AB 2016-06-15 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Sodium Phenylbutyrate
Listing expiration 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 984105 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 49884-006-04 Sodium Phenylbutyrate 250 g in 1 BOTTLE POWDER 250 10 49884-006-04 Sodium Phenylbutyrate 1 in 1 CARTON POWDER 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49884-006 SODIUM PHENYLBUTYRATE POWDER [ENDO USA, INC.] 9 Current NDC, Legacy NDC, 2 package rows 20240820_639f5c7e-9f6d-47fb-a417-2be076176a78.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 49884-006-04 49884000604 1 BOTTLE in 1 CARTON (49884-006-04) / 250 g in 1 BOTTLE 1 bottle 2016-08-31 0000-00-00 No No Current