FDA.reportPublic FDA data

Sodium Phenylacetate and Sodium Benzoate

Product NDC
72266-236
11-digit product format
722660236
Labeler code
72266
Product ID
72266-236_18084634-4c12-58ee-e063-6294a90ac7d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Phenylacetate and Sodium Benzoate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
FOSUN PHARMA USA INC
Application
NDA215025
Marketing category
NDA
Marketing start
2021-11-14
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
72266-236-01Sodium Phenylacetate and Sodium Benzoate1 in 1 CARTONINJECTION12
72266-236-01Sodium Phenylacetate and Sodium Benzoate20 mL in 1 VIAL, SINGLE-DOSEINJECTION202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72266-236-01ML - Milliliter72266-236589842ce-d775-4282-9e5a-7cb56792b5a812022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72266-236SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION [FOSUN PHARMA USA INC]2Current NDC, Legacy NDC, 2 package rows20240510_cee1e9a2-bbe5-2419-e053-2a95a90ac3ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2560228sodium benzoate 10 % / sodium phenylacetate 10 % in 20 ML InjectionPSNcee1e9a2-bbe5-2419-e053-2a95a90ac3ef2
256022820 ML sodium benzoate 100 MG/ML / sodium phenylacetate 100 MG/ML InjectionSCDcee1e9a2-bbe5-2419-e053-2a95a90ac3ef2
2560228sodium benzoate 10 % / sodium phenylacetate 10 % per 20 ML InjectionSYcee1e9a2-bbe5-2419-e053-2a95a90ac3ef2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72266-236-01722660236011 VIAL, SINGLE-DOSE in 1 CARTON (72266-236-01) / 20 mL in 1 VIAL, SINGLE-DOSE2021-11-140000-00-00NoNoCurrent