Home NDC 0121-1049 Glycerol Phenylbutyrate
Product NDC 0121-1049
11-digit product format 001211049
Labeler code 0121
Product ID 0121-1049_8e05336e-2d56-44e5-a76b-5b39f2f26a0f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glycerol Phenylbutyrate
Dosage form LIQUID
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA220579
Marketing category ANDA
Marketing start 2026-10-12
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 44 .
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 A220579-001 GLYCEROL PHENYLBUTYRATE GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL AA 2026-07-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220579-001 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 2026-10-15 13:18:30 2026-09 A220579-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL AA 2026-07-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 A220579-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL AA 2026-07-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220579-001 GLYCEROL PHENYLBUTYRATE 1.1GM/ML LIQUID / ORAL AA 2026-07-28 caaa826d4ba7…
Observed Orange Book normalized TE history# 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0121-1049-25 00121104925 1 BOTTLE in 1 CARTON (0121-1049-25) / 25 mL in 1 BOTTLE 1 bottle 2026-10-12 No No Current