FDA.reportPublic FDA data

Glycerol phenylbutyrate

Product NDC
72205-331
11-digit product format
722050331
Labeler code
72205
Product ID
72205-331_b4dc2c81-3b30-4bb8-af7d-4d093981c386
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glycerol phenylbutyrate
Dosage form
LIQUID
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA219540
Marketing category
ANDA
Marketing start
2026-04-15
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 1.

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
A219540-001GLYCEROL PHENYLBUTYRATEGLYCEROL PHENYLBUTYRATE1.1GM/MLLIQUID / ORALAA2026-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219540-001AA

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
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219540-001GLYCEROL PHENYLBUTYRATE1.1GM/MLLIQUID / ORALAA2026-04-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219540-001AA1a50c72e98297…

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
b4dc2c81-3b30-4bb8-af7d-4d093981c386Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0cc537b1-c2e1-c627-bac5-cebf6929cf73Product name320240109
5b2d409d-7740-4999-9561-96950a3ff604Product name120230919
33ad3946-5a41-4c5a-ac56-c03c9275532fProduct name120230313
80e18c01-dd53-4091-b66d-ad9549805dabProduct name120221116
f6fdd4e1-690e-487f-b950-ea9fa2ba47d1Product name120170711
d43c7982-5d28-8a36-d1c0-93d0f3b1ada4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-331-57Glycerol phenylbutyrate1 in 1 CARTONLIQUID11
72205-331-57Glycerol phenylbutyrate25 mL in 1 BOTTLELIQUID251
72205-331-58Glycerol phenylbutyrate25 mL in 1 BOTTLELIQUID251
72205-331-58Glycerol phenylbutyrate4 in 1 CARTONLIQUID41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-331-57ML - Milliliter72205-331265ea50b-f0d5-4def-8814-d99c3579149012026-05-22

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glycerol phenylbutyrateGLYCEROL PHENYLBUTYRATENovadoz Pharmaceuticals LLCb4dc2c81-3b30-4bb8-af7d-4d093981c3862026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219540
application number: ANDA219540
ndc (product): 72205-331

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1368453glycerol phenylbutyrate 1.1 GM in 1 mL Oral SolutionPSNb4dc2c81-3b30-4bb8-af7d-4d093981c3861
1368453glycerol phenylbutyrate 1100 MG/ML Oral SolutionSCDb4dc2c81-3b30-4bb8-af7d-4d093981c3861
1368453glycerol phenylbutyrate 1.1 GM per 1 ML Oral SolutionSYb4dc2c81-3b30-4bb8-af7d-4d093981c3861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-331-57722050331571 BOTTLE in 1 CARTON (72205-331-57) / 25 mL in 1 BOTTLE1 bottle2026-04-16NoNoCurrent
72205-331-58722050331584 BOTTLE in 1 CARTON (72205-331-58) / 25 mL in 1 BOTTLE4 bottle2026-04-16NoNoCurrent