Home NDC 68475-807 Glycerol Phenylbutyrate
Product NDC 68475-807
11-digit product format 684750807
Labeler code 68475
Product ID 68475-807_209d6843-10de-43fc-9ae1-2cfd2ff8ee6c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glycerol Phenylbutyrate
Dosage form LIQUID
Route ORAL
Labeler Navinta LLC
Application ANDA220568
Marketing category ANDA
Marketing start 2026-07-11
Substance GLYCEROL PHENYLBUTYRATE
Active strength 1.1 g/mL
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 43 .
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 A220568-001 GLYCEROL PHENYLBUTYRATE GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL AA 2026-04-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220568-001 AA
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 2026-09-14 22:38:34 2026-08 A220568-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL AA 2026-04-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220568-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL AA 2026-04-23 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220568-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL AA 2026-04-23 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A220568-001 AA 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220568-001 AA 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220568-001 AA 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Glycerol Phenylbutyrate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYCEROL PHENYLBUTYRATE 1.1 g/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ZH6F1VCV7B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1368453 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68475-807-01 68475080701 1 BOTTLE in 1 CARTON (68475-807-01) / 25 mL in 1 BOTTLE 1 bottle 2026-07-11 No No Current