FDA.reportPublic FDA data

SODIUM PHENYLACETATE and SODIUM BENZOATE

Product NDC
81665-203
11-digit product format
816650203
Labeler code
81665
Product ID
81665-203_ab598188-342a-419e-9471-a7b60a25b198
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium phenylacetate and sodium benzoate
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Omnivium Pharmaceuticals LLC
Application
ANDA207096
Marketing category
ANDA
Marketing start
2025-02-25
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
81665-203-01SODIUM PHENYLACETATE and SODIUM BENZOATE50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE501
81665-203-01SODIUM PHENYLACETATE and SODIUM BENZOATE1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81665-203-01ML - Milliliter81665-203cf04a7ba-06b8-435c-848e-7f896a49f73e12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81665-203SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION, SOLUTION, CONCENTRATE [OMNIVIUM PHARMACEUTICALS LLC]1Current NDC, 2 package rows20250402_9067c301-74f9-457a-9b0f-b7e9b06a3508.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
984118sodium benzoate 10 % / sodium phenylacetate 10 % in 50 ML InjectionPSN9067c301-74f9-457a-9b0f-b7e9b06a35081
98411850 ML sodium benzoate 100 MG/ML / sodium phenylacetate 100 MG/ML InjectionSCD9067c301-74f9-457a-9b0f-b7e9b06a35081
984118sodium benzoate 10 % / sodium phenylacetate 10 % per 50 ML InjectionSY9067c301-74f9-457a-9b0f-b7e9b06a35081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
81665-203-01816650203011 VIAL, SINGLE-DOSE in 1 CARTON (81665-203-01) / 50 mL in 1 VIAL, SINGLE-DOSE2025-02-25NoNoHistorical