FDA.reportPublic FDA data

Sodium Phenylbutyrate

Product NDC
49884-170
11-digit product format
498840170
Labeler code
49884
Product ID
49884-170_2bf2608e-f953-4123-98f8-05122fd6e10d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Phenylbutyrate Tablets, 500 mg
Dosage form
TABLET
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA204395
Marketing category
ANDA
Marketing start
2016-04-29
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Phenylbutyrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM PHENYLBUTYRATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNT6K61736T
Rxcui199369

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
49884-170-04Sodium Phenylbutyrate250 in 1 BOTTLETABLET25010
49884-170-04Sodium Phenylbutyrate1 in 1 CARTONTABLET110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-170-04EA - Each49884-1704b0d8b5b-bf79-4b02-aaf4-50341526660512017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-170SODIUM PHENYLBUTYRATE (SODIUM PHENYLBUTYRATE TABLETS, 500 MG) TABLET [ENDO USA, INC.]9Current NDC, Legacy NDC, 2 package rows20240820_4020b962-eaee-4184-b04b-14ca757c51a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199369sodium phenylbutyrate 500 MG Oral TabletPSN4020b962-eaee-4184-b04b-14ca757c51a110
199369sodium phenylbutyrate 500 MG Oral TabletSCD4020b962-eaee-4184-b04b-14ca757c51a110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-170-04498840170041 BOTTLE in 1 CARTON (49884-170-04) / 250 TABLET in 1 BOTTLE1 bottle2016-04-290000-00-00NoNoCurrent