FDA.reportPublic FDA data

SODIUM PHENYLACETATE and SODIUM BENZOATE

Product NDC
70556-100
11-digit product format
705560100
Labeler code
70556
Product ID
70556-100_96dcfe63-d5ed-4ab1-810b-ebb035c58ecb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium phenylacetate and sodium benzoate
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Ailex Pharmaceuticals, LLC
Application
ANDA207096
Marketing category
ANDA
Marketing start
2016-02-24
Substance
SODIUM BENZOATE; SODIUM PHENYLACETATE
Active strength
100; 100 mg/mL; mg/mL
Pharmacologic classes
Ammonium Ion Binding Activity [MoA], Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC], 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 PHENYLACETATE and SODIUM BENZOATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM BENZOATE100 mg/mL
SODIUM PHENYLACETATE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOJ245FE5EU, 48N6U1781G
Rxcui984118

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70556-100-502025-03-30C16284748780-1d6a99b39-b5db-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use SODIUM PHENYLACETATE and SODIUM BENZOATE INJECTION, 10%/10% safely and effectively. See full prescribing information for SODIUM PHENYLACETATE and SODIUM BENZOATE INJECTION, 10%/10%. SODIUM PHENYLACETATE and SODIUM BENZOATE Injection, for intravenous use Initial U.S. Approval: 1987
70556-100-502022-01-28C16284748780-1d6a99b39-b5db-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use SODIUM PHENYLACETATE and SODIUM BENZOATE INJECTION, 10%/10% safely and effectively. See full prescribing information for SODIUM PHENYLACETATE and SODIUM BENZOATE INJECTION, 10%/10%. SODIUM PHENYLACETATE and SODIUM BENZOATE Injection, for intravenous use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70556-100-50SODIUM PHENYLACETATE and SODIUM BENZOATE1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE14
70556-100-50SODIUM PHENYLACETATE and SODIUM BENZOATE50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70556-100SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION, SOLUTION, CONCENTRATE [AILEX PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20250402_329655ae-c3c0-46b2-a925-e49777f2076b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
984118sodium benzoate 10 % / sodium phenylacetate 10 % in 50 ML InjectionPSN329655ae-c3c0-46b2-a925-e49777f2076b4
98411850 ML sodium benzoate 100 MG/ML / sodium phenylacetate 100 MG/ML InjectionSCD329655ae-c3c0-46b2-a925-e49777f2076b4
984118sodium benzoate 10 % / sodium phenylacetate 10 % per 50 ML InjectionSY329655ae-c3c0-46b2-a925-e49777f2076b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70556-100-50705560100501 VIAL, SINGLE-DOSE in 1 CARTON (70556-100-50) / 50 mL in 1 VIAL, SINGLE-DOSE2016-02-260000-00-00NoNoCurrent