FDA.reportPublic FDA data

Glycerol Phenylbutyrate

Product NDC
0121-1049
11-digit product format
001211049
Labeler code
0121
Product ID
0121-1049_9369d7b7-c7ba-4dc3-9a3d-13c0ed41e00f
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220579-001GLYCEROL PHENYLBUTYRATEGLYCEROL PHENYLBUTYRATE1.1GM/MLLIQUID / ORALAA2026-07-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A220579-001AA

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A220579-001GLYCEROL PHENYLBUTYRATE1.1GM/MLLIQUID / ORALAA2026-07-28c2088c7a36db…
2026-09-14 22:38:342026-08A220579-001GLYCEROL PHENYLBUTYRATE1.1GM/MLLIQUID / ORALAA2026-07-2884e616aacf4f…
2026-08-18 06:07:402026-07A220579-001GLYCEROL PHENYLBUTYRATE1.1GM/MLLIQUID / ORALAA2026-07-28caaa826d4ba7…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A220579-001AA1c2088c7a36db…
2026-09-14 22:38:342026-08A220579-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A220579-001AA1caaa826d4ba7…

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
IngredientStrength
GLYCEROL PHENYLBUTYRATE1.1 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ZH6F1VCV7BInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1368453Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
35855917-12cb-4c18-b7c5-5f275c1c80f0Available on FDA.report

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0121-1049-25001211049251 BOTTLE in 1 CARTON (0121-1049-25) / 25 mL in 1 BOTTLE1 bottle2026-10-12NoNoCurrent