FDA.reportPublic FDA data

Ammonul

Product NDC
62592-720
11-digit product format
625920720
Labeler code
62592
Product ID
62592-720_6295e473-526f-1f28-e053-2a91aa0a3a83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium phenylacetate and sodium benzoate
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Ucyclyd Pharma Inc.
Application
NDA020645
Marketing category
NDA
Marketing start
2005-02-17
Marketing end
0000-00-00
Substance
SODIUM PHENYLACETATE; SODIUM BENZOATE
Active strength
100 mg/mL; mg/mL
Pharmacologic classes
Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
62592-720-502020-01-31C16284748780-19d75b9d0-68ad-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMMONUL ® safely and effectively. See full prescribing information for AMMONUL ® AMMONUL ® (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
62592-720-50Ammonul1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE17
62592-720-50Ammonul50 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION, CONCENTRATE507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62592-720-50ML - Milliliter62592-7207664cfb8-690c-4615-857a-11bb9f4602be12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
sodium benzoateACTIVE INGREDIENTOJ245FE5EUAMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [UCYCLYD PHARMA INC.]6
sodium phenylacetateACTIVE INGREDIENT48N6U1781GAMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [UCYCLYD PHARMA INC.]6
benzoic acidACTIVE MOIETY8SKN0B0MIMAMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [UCYCLYD PHARMA INC.]6
phenylacetic acidACTIVE MOIETYER5I1W795AAMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [UCYCLYD PHARMA INC.]6
hydrochloric acidINACTIVE INGREDIENTQTT17582CBAMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [UCYCLYD PHARMA INC.]6
sodium hydroxideINACTIVE INGREDIENT55X04QC32IAMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [UCYCLYD PHARMA INC.]6
waterINACTIVE INGREDIENT059QF0KO0RAMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [UCYCLYD PHARMA INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62592-720AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [UCYCLYD PHARMA INC.]7Legacy NDC, 2 package rows20180115_d564f2b1-9fc7-4201-8066-d745ac3a671f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
984120AMMONUL 10 % / 10 % in 50 ML InjectionPSNd564f2b1-9fc7-4201-8066-d745ac3a671f7
984118sodium benzoate 10 % / sodium phenylacetate 10 % in 50 ML InjectionPSNd564f2b1-9fc7-4201-8066-d745ac3a671f7
98412050 ML sodium benzoate 100 MG/ML / sodium phenylacetate 100 MG/ML Injection [Ammonul]SBDd564f2b1-9fc7-4201-8066-d745ac3a671f7
98411850 ML sodium benzoate 100 MG/ML / sodium phenylacetate 100 MG/ML InjectionSCDd564f2b1-9fc7-4201-8066-d745ac3a671f7
984120Ammonul (sodium benzoate 10 % / sodium phenylacetate 10 % ) in 50 ML InjectionSYd564f2b1-9fc7-4201-8066-d745ac3a671f7
984118sodium benzoate 10 % / sodium phenylacetate 10 % per 50 ML InjectionSYd564f2b1-9fc7-4201-8066-d745ac3a671f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
62592-720-50625920720501 in 1 CARTONHistorical