Home DailyMed 34eaa60b-4e73-4c0e-a8d7-f995335386f7 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2013-02-13
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 03:38:57 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 c2088c7a36db…2026-09-14 22:38:34 2026-08 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203441-001 GATTEX KIT 5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-12-21 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 1 of 17 · 672 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N203441-001 7847061 2025-11-01 U-1320 Delist requested 2013-01-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203441-001 9060992 2025-11-01 U-1320 Delist requested 2015-07-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203441-001 7847061*PED 2026-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N203441-001 9060992*PED 2026-05-01 Pediatric extension c2088c7a36db…2026-09-14 22:38:34 2026-08 N203441-001 7847061 2025-11-01 U-1320 Delist requested 2013-01-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203441-001 9060992 2025-11-01 U-1320 Delist requested 2015-07-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203441-001 7847061*PED 2026-05-01 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203441-001 9060992*PED 2026-05-01 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203441-001 7847061 2025-11-01 U-1320 Delist requested 2013-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203441-001 9060992 2025-11-01 U-1320 Delist requested 2015-07-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203441-001 7847061*PED 2026-05-01 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203441-001 9060992*PED 2026-05-01 Pediatric extension caaa826d4ba7…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…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 54 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.