FDA.reportPublic FDA data

Endari

Product NDC
42457-420
11-digit product format
424570420
Labeler code
42457
Product ID
42457-420_10f5d160-6687-44d5-a607-6bf69a7312b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glutamine
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Emmaus Medical, Inc.
Application
NDA208587
Marketing category
NDA
Marketing start
2017-07-07
Substance
GLUTAMINE
Active strength
5 g/1
Pharmacologic classes
Amino Acid [EPC], Amino Acids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Endari
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLUTAMINE5 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0RH81L854J
Rxcui1869684, 1928941

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
73df98bc-429f-4587-8299-6ad8d52a4f36Product name220250304
64b87b8d-6ae7-cef1-8fd2-34228b0cc1bcProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42457-420-602022-08-19C16284748780-1d6a99b39-fe74-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ENDARI™ safely and effectively. See full prescribing information for ENDARI. ENDARI (L-glutamine oral powder ) Initial U.S. Approval: 2017
42457-420-602022-01-28C16284748780-1d6a99b39-fe74-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ENDARI™ safely and effectively. See full prescribing information for ENDARI. ENDARI (L-glutamine oral powder ) Initial U.S. Approval: 2017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42457-420-01Endari1 in 1 PACKETPOWDER, FOR SOLUTION110
42457-420-60Endari60 in 1 CARTONPOWDER, FOR SOLUTION6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42457-420-01EA - Each42457-42016857e27-1feb-4dc0-ba9c-1158f29e991912017-10-13
42457-420-60EA - Each42457-420bd1af523-a76c-469d-bb00-dcda025ec01212017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42457-420ENDARI (GLUTAMINE) POWDER, FOR SOLUTION [EMMAUS MEDICAL, INC.]8Current NDC, Legacy NDC, 2 package rows20220820_d5a783f4-12ef-4326-8faa-40018e45ba3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1928941Endari 5 GM Powder for Oral SolutionPSNd5a783f4-12ef-4326-8faa-40018e45ba3b10
1869684glutamine 5 GM Powder for Oral SolutionPSNd5a783f4-12ef-4326-8faa-40018e45ba3b10
1928941glutamine 5000 MG Powder for Oral Solution [Endari]SBDd5a783f4-12ef-4326-8faa-40018e45ba3b10
1869684glutamine 5000 MG Powder for Oral SolutionSCDd5a783f4-12ef-4326-8faa-40018e45ba3b10
1928941Endari 5000 MG Powder for Oral SolutionSYd5a783f4-12ef-4326-8faa-40018e45ba3b10
1869684l-glutamine 5 GM Powder for Oral SolutionSYd5a783f4-12ef-4326-8faa-40018e45ba3b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42457-420-01424570420011 in 1 PACKETHistorical
42457-420-604245704206060 PACKET in 1 CARTON (42457-420-60) / 1 POWDER, FOR SOLUTION in 1 PACKET (42457-420-01) 60 packet2017-07-070000-00-00NoNoCurrent