FDA.reportPublic FDA data

Sodium phenylacetate and Sodium benzoate

Product NDC
70710-1926
11-digit product format
707101926
Labeler code
70710
Product ID
70710-1926_fd646c47-7fcd-4d60-8f6c-29e13f611c6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium phenylacetate and Sodium benzoate
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA217526
Marketing category
ANDA
Marketing start
2023-09-19
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
Rxcui2560228

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1926-1Sodium phenylacetate and Sodium benzoate1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE15
70710-1926-1Sodium phenylacetate and Sodium benzoate20 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1926-1ML - Milliliter70710-1926f89f078c-9abd-48af-8e8a-84f466af57a812023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1926SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION, SOLUTION, CONCENTRATE [ZYDUS PHARMACEUTICALS USA INC.]5Current NDC, 2 package rows20231101_0f17c50f-3761-4470-bf3b-63837a287b8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2560228sodium benzoate 10 % / sodium phenylacetate 10 % in 20 ML InjectionPSN0f17c50f-3761-4470-bf3b-63837a287b8a5
256022820 ML sodium benzoate 100 MG/ML / sodium phenylacetate 100 MG/ML InjectionSCD0f17c50f-3761-4470-bf3b-63837a287b8a5
2560228sodium benzoate 10 % / sodium phenylacetate 10 % per 20 ML InjectionSY0f17c50f-3761-4470-bf3b-63837a287b8a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-1926-1707101926011 VIAL in 1 CARTON (70710-1926-1) / 20 mL in 1 VIAL1 vial2023-09-19NoNoCurrent