Home NDC 70954-417 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 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 A215647-001 L-GLUTAMINE L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA 2024-07-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215647-001 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 A215647-001 L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA 2024-07-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215647-001 L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA 2024-07-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215647-001 L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA 2024-07-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215647-001 L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA 2024-07-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215647-001 L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA 2024-07-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215647-001 L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA 2024-07-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215647-001 L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA 2024-07-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215647-001 L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA 2024-07-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215647-001 L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA 2024-07-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215647-001 L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA 2024-07-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215647-001 L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA 2024-07-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215647-001 L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA 2024-07-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215647-001 L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA 2024-07-08 301d65b070ca…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215647-001 L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA 2024-07-08 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base L-Glutamine
Listing expiration 2026-12-31 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 70954-417-10 L-Glutamine 1 in 1 PACKET POWDER, FOR SOLUTION 1 2 70954-417-20 L-Glutamine 60 in 1 CARTON POWDER, FOR SOLUTION 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-417 L-GLUTAMINE POWDER, FOR SOLUTION [ANI PHARMACEUTICALS, INC.] 1 Current NDC, 2 package rows 20240712_bb4ec712-14b7-47e3-8cb9-c71922712e55.zip
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 70954-417-10 70954041710 1 in 1 PACKET Historical 70954-417-20 70954041720 60 PACKET in 1 CARTON (70954-417-20) / 1 POWDER, FOR SOLUTION in 1 PACKET (70954-417-10) 60 packet 2024-07-11 No No Current