FDA.reportPublic FDA data

Ravicti

Product NDC
75987-050
11-digit product format
759870050
Labeler code
75987
Product ID
75987-050_a58b617c-635a-4a67-9f27-f9c93f8cba22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glycerol phenylbutyrate
Dosage form
LIQUID
Route
ORAL
Labeler
Horizon Therapeutics USA, Inc.
Application
NDA203284
Marketing category
NDA
Marketing start
2013-02-28
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ravicti
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCEROL PHENYLBUTYRATE1.1 g/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZH6F1VCV7B
Rxcui1368453, 1368459

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
75987-050-06Ravicti25 mL in 1 BOTTLELIQUID2513
75987-050-06Ravicti1 in 1 CARTONLIQUID113
75987-050-07Ravicti25 mL in 1 BOTTLELIQUID2513
75987-050-07Ravicti4 in 1 CARTONLIQUID413

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75987-050-06ML - Milliliter75987-050588316b1-3c09-404b-bd09-f3b37c6d26f612015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCEROL PHENYLBUTYRATEACTIVE INGREDIENTZH6F1VCV7BRAVICTI (GLYCEROL PHENYLBUTYRATE) LIQUID [HORIZON PHARMA, INC.]1
GLYCEROL PHENYLBUTYRATEACTIVE MOIETYZH6F1VCV7BRAVICTI (GLYCEROL PHENYLBUTYRATE) LIQUID [HORIZON PHARMA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75987-050RAVICTI (GLYCEROL PHENYLBUTYRATE) LIQUID [HORIZON THERAPEUTICS USA, INC.]12Current NDC, Legacy NDC, 4 package rows20240509_900e7dc0-9afe-4f50-80de-90567bb78519.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1368453glycerol phenylbutyrate 1.1 GM in 1 mL Oral SolutionPSN900e7dc0-9afe-4f50-80de-90567bb7851913
1368459RAVICTI 1.1 GM in 1 mL Oral SolutionPSN900e7dc0-9afe-4f50-80de-90567bb7851913
1368459glycerol phenylbutyrate 1100 MG/ML Oral Solution [Ravicti]SBD900e7dc0-9afe-4f50-80de-90567bb7851913
1368453glycerol phenylbutyrate 1100 MG/ML Oral SolutionSCD900e7dc0-9afe-4f50-80de-90567bb7851913
1368453glycerol phenylbutyrate 1.1 GM per 1 ML Oral SolutionSY900e7dc0-9afe-4f50-80de-90567bb7851913
1368459Ravicti 1100 MG/ML Oral SolutionSY900e7dc0-9afe-4f50-80de-90567bb7851913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75987-050-06759870050061 BOTTLE in 1 CARTON (75987-050-06) / 25 mL in 1 BOTTLE1 bottle2013-02-280000-00-00NoNoCurrent
75987-050-07759870050074 BOTTLE in 1 CARTON (75987-050-07) / 25 mL in 1 BOTTLE4 bottle2013-02-280000-00-00NoNoCurrent