Home NDC 84897-057 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219750-001 L-GLUTAMINE L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA 2026-05-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219750-001 AA
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A219750-001 L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA 2026-05-14 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219750-001 L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA 2026-05-14 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A219750-001 AA 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219750-001 AA 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base L-glutamine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLUTAMINE 5 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0RH81L854J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1869684 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84897-057-01 L-glutamine 1 in 1 PACKET POWDER, FOR SOLUTION 1 2 84897-057-60 L-glutamine 60 in 1 CARTON POWDER, FOR SOLUTION 60 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84897-057-01 84897005701 1 in 1 PACKET Historical 84897-057-60 84897005760 60 PACKET in 1 CARTON (84897-057-60) / 1 POWDER, FOR SOLUTION in 1 PACKET (84897-057-01) 60 packet 2026-05-19 No No Current