FDA.reportPublic FDA data

Sodium Phenylacetate and sodium benzoate

Product NDC
68475-001
11-digit product format
684750001
Labeler code
68475
Product ID
68475-001_e2b1772b-057e-4c1a-a3e1-6bbf7c2d770e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Phenylacetate and sodium benzoate
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Navinta LLC
Application
ANDA205880
Marketing category
ANDA
Marketing start
2021-03-04
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68475-001-50Sodium Phenylacetate and sodium benzoate50 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE506
68475-001-50Sodium Phenylacetate and sodium benzoate1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68475-001SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION, SOLUTION, CONCENTRATE [NAVINTA LLC]6Current NDC, Legacy NDC, 2 package rows20241001_fbc7bfe3-6faa-45a3-befb-9ad7963c0571.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
984118sodium benzoate 10 % / sodium phenylacetate 10 % in 50 ML InjectionPSNfbc7bfe3-6faa-45a3-befb-9ad7963c05716
98411850 ML sodium benzoate 100 MG/ML / sodium phenylacetate 100 MG/ML InjectionSCDfbc7bfe3-6faa-45a3-befb-9ad7963c05716
984118sodium benzoate 10 % / sodium phenylacetate 10 % per 50 ML InjectionSYfbc7bfe3-6faa-45a3-befb-9ad7963c05716

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68475-001-50684750001501 VIAL in 1 CARTON (68475-001-50) / 50 mL in 1 VIAL1 vial2021-03-040000-00-00NoNoCurrent