Home NDC 70710-2180 Sodium phenylbutyrate
Product NDC 70710-2180
11-digit product format 707102180
Labeler code 70710
Product ID 70710-2180_47ef97e0-8853-4254-b969-1a489764cec1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium phenylbutyrate
Dosage form TABLET
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA220418
Marketing category ANDA
Marketing start 2026-03-23
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 A220418-001 SODIUM PHENYLBUTYRATE SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2026-02-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220418-001 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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220418-001 SODIUM PHENYLBUTYRATE 500MG TABLET / ORAL AB 2026-02-17 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220418-001 AB 1 a50c72e98297…
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 70710-2180-8 Sodium phenylbutyrate 250 in 1 BOTTLE TABLET 250 2 70710-2180-8 Sodium phenylbutyrate 1 in 1 CARTON TABLET 1 2
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70710-2180-8 70710218008 1 BOTTLE in 1 CARTON (70710-2180-8) / 250 TABLET in 1 BOTTLE 1 bottle 2026-03-23 No No Current