L-glutamine

Product NDC
84897-057
11-digit product format
848970057
Labeler code
84897
Product ID
84897-057_84675cdf-a3f0-4a1d-a69e-d46f573a7891
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
L-glutamine
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Renova Pharmaceuticals LLC
Application
ANDA219750
Marketing category
ANDA
Marketing start
2026-05-14
Substance
GLUTAMINE
Active strength
5 g/1
Pharmacologic classes
Amino Acid [EPC], Amino Acids [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
L-glutamine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLUTAMINE5 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0RH81L854J
Rxcui1869684

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84897-057-01L-glutamine1 in 1 PACKETPOWDER, FOR SOLUTION12
84897-057-60L-glutamine60 in 1 CARTONPOWDER, FOR SOLUTION602

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1869684glutamine 5 GM Powder for Oral SolutionPSN3f324755-159b-40ee-a9f4-e6800558acf32
1869684glutamine 5000 MG Powder for Oral SolutionSCD3f324755-159b-40ee-a9f4-e6800558acf32
1869684l-glutamine 5 GM Powder for Oral SolutionSY3f324755-159b-40ee-a9f4-e6800558acf32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84897-057-01848970057011 in 1 PACKETHistorical
84897-057-608489700576060 PACKET in 1 CARTON (84897-057-60) / 1 POWDER, FOR SOLUTION in 1 PACKET (84897-057-01) 60 packet2026-05-19NoNoHistorical