Home NDC 68462-853 sodium phenylbutyrate
Product NDC 68462-853
11-digit product format 684620853
Labeler code 68462
Product ID 68462-853_060b5266-8881-4270-b62d-df8e49ecfd4b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sodium phenylbutyrate
Dosage form TABLET
Route ORAL
Labeler GLENMARK PHARMACEUTICALS INC., USA
Application ANDA216462
Marketing category ANDA
Marketing start 2022-11-01
Substance SODIUM PHENYLBUTYRATE
Active strength 500 mg/1
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 A216462-001 SODIUM PHENYLBUTYRATE SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216462-001 AB
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 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 3a93d1ddd44b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216462-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2022-11-01 a50c72e98297…
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 500 mg/1
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 199369 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 68462-853-20 sodium phenylbutyrate 250 in 1 BOTTLE TABLET 250 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-853 SODIUM PHENYLBUTYRATE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 2 Current NDC, Legacy NDC, 1 package rows 20240103_0c76d25b-abac-41a3-a547-4fa4796bf7a4.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 68462-853-20 68462085320 250 TABLET in 1 BOTTLE (68462-853-20) 250 tablet 2022-11-01 0000-00-00 No No Current