Home NDC 31722-483 L-glutamine
Product NDC 31722-483
11-digit product format 317220483
Labeler code 31722
Product ID 31722-483_53e2f942-3586-664c-e063-6294a90ab92b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name L-glutamine
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA219722
Marketing category ANDA
Marketing start 2026-05-26
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 43 .
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 A219722-001 L-GLUTAMINE L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA 2026-05-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219722-001 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 2026-09-14 22:38:34 2026-08 A219722-001 L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA 2026-05-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219722-001 L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA 2026-05-26 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219722-001 L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA 2026-05-26 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A219722-001 AA 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219722-001 AA 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219722-001 AA 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 31722-483-60 31722048360 60 PACKET in 1 CARTON (31722-483-60) / 1 POWDER, FOR SOLUTION in 1 PACKET 60 packet 2026-05-26 No No Current