Home NDC 42457-420 Endari
Product NDC 42457-420
11-digit product format 424570420
Labeler code 42457
Product ID 42457-420_10f5d160-6687-44d5-a607-6bf69a7312b6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glutamine
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Emmaus Medical, Inc.
Application NDA208587
Marketing category NDA
Marketing start 2017-07-07
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 42457-420-60 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 42457-420-60 bd6a592717d7…303034d00443…
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 N208587-001 ENDARI L-GLUTAMINE 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N208587-001 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.
Product history page 1 of 2 · 42 observed 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 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL AA RLD 2017-07-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208587-001 ENDARI 5GM/PACKET FOR SOLUTION / ORAL RLD 2017-07-07 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Endari
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1869684 Internal RxNorm lookup 1928941 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42457-420-01 Endari 1 in 1 PACKET POWDER, FOR SOLUTION 1 10 42457-420-60 Endari 60 in 1 CARTON POWDER, FOR SOLUTION 60 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42457-420 ENDARI (GLUTAMINE) POWDER, FOR SOLUTION [EMMAUS MEDICAL, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20220820_d5a783f4-12ef-4326-8faa-40018e45ba3b.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 Marketing end Sample Exclude flag Status 42457-420-01 42457042001 1 in 1 PACKET Historical 42457-420-60 42457042060 60 PACKET in 1 CARTON (42457-420-60) / 1 POWDER, FOR SOLUTION in 1 PACKET (42457-420-01) 60 packet 2017-07-07 0000-00-00 No No Current