FDA.reportPublic FDA data

Sodium Phenylbutyrate

Product NDC
42794-086
11-digit product format
427940086
Labeler code
42794
Product ID
42794-086_d70f7f7c-f27a-db94-e053-2995a90a6937
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Phenylbutyrate
Dosage form
POWDER
Route
ORAL
Labeler
Sigmapharm Laboratories, LLC
Application
ANDA202819
Marketing category
ANDA
Marketing start
2013-04-08
Substance
SODIUM PHENYLBUTYRATE
Active strength
.94 g/g
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
Sodium Phenylbutyrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM PHENYLBUTYRATE.94 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNT6K61736T
Rxcui984105

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
42794-086-14Sodium Phenylbutyrate250 g in 1 BOTTLEPOWDER2505
42794-086-14Sodium Phenylbutyrate1 in 1 CARTONPOWDER15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42794-086-14GM - Gram42794-0869f48ab0c-c035-4855-8e75-5aedc085d92a12013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM PHENYLBUTYRATEACTIVE INGREDIENTNT6K61736TSODIUM PHENYLBUTYRATE POWDER [SIGMAPHARM LABORATORIES, LLC]1
PHENYLBUTYRIC ACIDACTIVE MOIETY7WY7YBI87ESODIUM PHENYLBUTYRATE POWDER [SIGMAPHARM LABORATORIES, LLC]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LSODIUM PHENYLBUTYRATE POWDER [SIGMAPHARM LABORATORIES, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SODIUM PHENYLBUTYRATE POWDER [SIGMAPHARM LABORATORIES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42794-086SODIUM PHENYLBUTYRATE POWDER [SIGMAPHARM LABORATORIES, LLC]5Current NDC, Legacy NDC, 2 package rows20220203_e914d451-6122-43f9-af8d-c80ed1cb215d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
984105sodium phenylbutyrate 0.94 GM/GM Oral PowderPSNe914d451-6122-43f9-af8d-c80ed1cb215d5
984105sodium phenylbutyrate 0.94 MG/MG Oral PowderSCDe914d451-6122-43f9-af8d-c80ed1cb215d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42794-086-14427940086141 BOTTLE in 1 CARTON (42794-086-14) / 250 g in 1 BOTTLE1 bottle2013-04-080000-00-00NoNoCurrent