Home NDC 68875-0101 Gattex
Product NDC 68875-0101
11-digit product format 688750101
Labeler code 68875
Product ID 68875-0101_20ca0019-d3a4-4a8f-8dd4-67179d06e4dc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name teduglutide
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route SUBCUTANEOUS
Labeler Takeda Pharmaceuticals America, Inc.
Application NDA203441
Marketing category NDA
Marketing start 2012-12-21
Substance TEDUGLUTIDE
Active strength 5 mg/.5mL
Pharmacologic classes Analogs/Derivatives [Chemical/Ingredient], GLP-2 Analog [EPC], Glucagon-Like Peptide 2 [Chemical/Ingredient], Glucagon-like Peptide-2 (GLP-2) Agonists [MoA]
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 1 .
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 N203441-001 GATTEX KIT TEDUGLUTIDE 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203441-001 7847061 2025-11-01 U-1320 Delist requested 2013-01-18 N203441-001 9060992 2025-11-01 U-1320 Delist requested 2015-07-17 N203441-001 7847061*PED 2026-05-01 Pediatric extension N203441-001 9060992*PED 2026-05-01 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N203441-001 ODE-240 2026-05-16
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 17 · 660 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N203441-001 7847061 2025-11-01 U-1320 Delist requested 2013-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203441-001 9060992 2025-11-01 U-1320 Delist requested 2015-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203441-001 7847061*PED 2026-05-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203441-001 9060992*PED 2026-05-01 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203441-001 7847061 2025-11-01 U-1320 Delist requested 2013-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203441-001 9060992 2025-11-01 U-1320 Delist requested 2015-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203441-001 7847061*PED 2026-05-01 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203441-001 9060992*PED 2026-05-01 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203441-001 7847061 2025-11-01 U-1320 Delist requested 2013-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203441-001 9060992 2025-11-01 U-1320 Delist requested 2015-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203441-001 7847061*PED 2026-05-01 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203441-001 9060992*PED 2026-05-01 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203441-001 7847061 2025-11-01 U-1320 Delist requested 2013-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203441-001 9060992 2025-11-01 U-1320 Delist requested 2015-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203441-001 7847061*PED 2026-05-01 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203441-001 9060992*PED 2026-05-01 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203441-001 7847061 2025-11-01 U-1320 Delist requested 2013-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203441-001 9060992 2025-11-01 U-1320 Delist requested 2015-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203441-001 7847061*PED 2026-05-01 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203441-001 9060992*PED 2026-05-01 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203441-001 7847061 2025-11-01 U-1320 Delist requested 2013-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203441-001 9060992 2025-11-01 U-1320 Delist requested 2015-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203441-001 7847061*PED 2026-05-01 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203441-001 9060992*PED 2026-05-01 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203441-001 7847061 2025-11-01 U-1320 Delist requested 2013-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203441-001 9060992 2025-11-01 U-1320 Delist requested 2015-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203441-001 7847061*PED 2026-05-01 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203441-001 9060992*PED 2026-05-01 Pediatric extension 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203441-001 7847061 2025-11-01 U-1320 Delist requested 2013-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203441-001 9060992 2025-11-01 U-1320 Delist requested 2015-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203441-001 7847061*PED 2026-05-01 Pediatric extension 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203441-001 9060992*PED 2026-05-01 Pediatric extension 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203441-001 7847061 2025-11-01 U-1320 Delist requested 2013-01-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203441-001 9060992 2025-11-01 U-1320 Delist requested 2015-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203441-001 7847061*PED 2026-05-01 Pediatric extension d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203441-001 9060992*PED 2026-05-01 Pediatric extension d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203441-001 7847061 2025-11-01 U-1320 Delist requested 2013-01-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203441-001 9060992 2025-11-01 U-1320 Delist requested 2015-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203441-001 7847061*PED 2026-05-01 Pediatric extension d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203441-001 9060992*PED 2026-05-01 Pediatric extension d06236e962d9…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 51 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Gattex
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TEDUGLUTIDE 5 mg/.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7M19191IKG Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1364472 Internal RxNorm lookup 1364477 Internal RxNorm lookup 1489307 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 68875-0101-1 Gattex 0.5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 0.5 mL 5 mg in 0.5mL 20 68875-0101-1 Gattex 0.5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 15 mL 5 mg in 0.5mL 20 68875-0101-1 Gattex 0.5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 0.5 20 68875-0101-2 Gattex 30 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 30 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded teduglutide ACTIVE INGREDIENT 7M19191IKG GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] 3 water ACTIVE INGREDIENT 059QF0KO0R GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] 3 teduglutide ACTIVE MOIETY 7M19191IKG GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] 3 water ACTIVE MOIETY 059QF0KO0R GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] 3 Histidine INACTIVE INGREDIENT 4QD397987E GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] 3 mannitol INACTIVE INGREDIENT 3OWL53L36A GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] 3 sodium phosphate, dibasic, heptahydrate INACTIVE INGREDIENT 70WT22SF4B GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] 3 sodium phosphate, monobasic, monohydrate INACTIVE INGREDIENT 593YOG76RN GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68875-0101 GATTEX (TEDUGLUTIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.] 19 Current NDC, Legacy NDC, 2 package rows 20241003_66b69c1e-b25c-44d3-b5ff-1c1de9a516fa.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gattex TEDUGLUTIDE Takeda Pharmaceuticals America, Inc. 66b69c1e-b25c-44d3-b5ff-1c1de9a516fa 2025-09-05 Warnings, Adverse reactions Exact identifier application applno (NDA): 203441 application number: NDA203441 ndc (product): 68875-0101
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 68875-0101-1 68875010101 0.5 mL in 1 VIAL 0.5 ml Historical 68875-0101-2 68875010102 30 VIAL in 1 CARTON (68875-0101-2) / .5 mL in 1 VIAL (68875-0101-1) 30 vial 2012-12-21 0000-00-00 No No Current