L-Glutamine

Product NDC
70954-417
11-digit product format
709540417
Labeler code
70954
Product ID
70954-417_0635706e-180e-435e-92cf-c85e0ca4f7e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
L-Glutamine
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA215647
Marketing category
ANDA
Marketing start
2024-07-11
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
L-Glutamine
Listing expiration
2026-12-31

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
70954-417-10L-Glutamine1 in 1 PACKETPOWDER, FOR SOLUTION12
70954-417-20L-Glutamine60 in 1 CARTONPOWDER, FOR SOLUTION602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-417-10EA - Each70954-4170d8f400b-5ea1-4444-a293-202a2a1c524a12024-08-12
70954-417-20EA - Each70954-417bece2a34-1f27-488e-a842-0830da06895812024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-417L-GLUTAMINE POWDER, FOR SOLUTION [ANI PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20240712_bb4ec712-14b7-47e3-8cb9-c71922712e55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1869684glutamine 5 GM Powder for Oral SolutionPSNbb4ec712-14b7-47e3-8cb9-c71922712e552
1869684glutamine 5000 MG Powder for Oral SolutionSCDbb4ec712-14b7-47e3-8cb9-c71922712e552
1869684l-glutamine 5 GM Powder for Oral SolutionSYbb4ec712-14b7-47e3-8cb9-c71922712e552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70954-417-10709540417101 in 1 PACKETHistorical
70954-417-207095404172060 PACKET in 1 CARTON (70954-417-20) / 1 POWDER, FOR SOLUTION in 1 PACKET (70954-417-10) 60 packet2024-07-11NoNoHistorical