FDA.reportPublic FDA data

BUPHENYL

Product NDC
75987-060
11-digit product format
759870060
Labeler code
75987
Product ID
75987-060_3178e0bc-ebb7-4ddd-be43-630ff87eeb02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium phenylbutyrate
Dosage form
TABLET
Route
ORAL
Labeler
Horizon Therapeutics USA, Inc.
Application
NDA020572
Marketing category
NDA
Marketing start
1996-05-13
Substance
SODIUM PHENYLBUTYRATE
Active strength
500 mg/1
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
BUPHENYL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM PHENYLBUTYRATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNT6K61736T
Rxcui199369, 213196, 984105, 984107

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75987-060-08BUPHENYL250 in 1 BOTTLETABLET2509
75987-060-08BUPHENYL1 in 1 CARTONTABLET19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75987-060-08EA - Each75987-060959eacf1-2cf4-478e-9961-2046e9875d7e12016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM PHENYLBUTYRATEACTIVE INGREDIENTNT6K61736TBUPHENYL (SODIUM PHENYLBUTYRATE) TABLET BUPHENYL (SODIUM PHENYLBUTYRATE) POWDER [HORIZON PHARMA, INC.]1
PHENYLBUTYRIC ACIDACTIVE MOIETY7WY7YBI87EBUPHENYL (SODIUM PHENYLBUTYRATE) TABLET BUPHENYL (SODIUM PHENYLBUTYRATE) POWDER [HORIZON PHARMA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75987-060BUPHENYL (SODIUM PHENYLBUTYRATE) TABLET BUPHENYL (SODIUM PHENYLBUTYRATE) POWDER [HORIZON THERAPEUTICS USA, INC.]9Current NDC, Legacy NDC, 2 package rows20241114_463a36fa-3eb2-4326-8bd0-c8c7a11bca3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
984107BUPHENYL 0.94 GM/GM Oral PowderPSN463a36fa-3eb2-4326-8bd0-c8c7a11bca3a9
213196Buphenyl 500 MG Oral TabletPSN463a36fa-3eb2-4326-8bd0-c8c7a11bca3a9
984105sodium phenylbutyrate 0.94 GM/GM Oral PowderPSN463a36fa-3eb2-4326-8bd0-c8c7a11bca3a9
199369sodium phenylbutyrate 500 MG Oral TabletPSN463a36fa-3eb2-4326-8bd0-c8c7a11bca3a9
984107sodium phenylbutyrate 0.94 MG/MG Oral Powder [Buphenyl]SBD463a36fa-3eb2-4326-8bd0-c8c7a11bca3a9
213196sodium phenylbutyrate 500 MG Oral Tablet [Buphenyl]SBD463a36fa-3eb2-4326-8bd0-c8c7a11bca3a9
984105sodium phenylbutyrate 0.94 MG/MG Oral PowderSCD463a36fa-3eb2-4326-8bd0-c8c7a11bca3a9
199369sodium phenylbutyrate 500 MG Oral TabletSCD463a36fa-3eb2-4326-8bd0-c8c7a11bca3a9
984107Buphenyl 0.94 MG/MG Oral PowderSY463a36fa-3eb2-4326-8bd0-c8c7a11bca3a9
213196Buphenyl 500 MG Oral TabletSY463a36fa-3eb2-4326-8bd0-c8c7a11bca3a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75987-060-08759870060081 BOTTLE in 1 CARTON (75987-060-08) / 250 TABLET in 1 BOTTLE1 bottle1996-05-130000-00-00NoNoCurrent