Home NDC 72126-007-01 Tegsedi
Product NDC 72126-007
Requested package NDC 72126-007-01
11-digit product format 721260007
Labeler code 72126
Product ID 72126-007_14be3820-eafc-42a9-b3dd-d4b0e6e57557
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name inotersen
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Akcea Therapeutics, Inc.
Application NDA211172
Marketing category NDA
Marketing start 2018-10-05
Marketing end 0000-00-00
Substance INOTERSEN SODIUM
Active strength 284 mg/1.5mL
Pharmacologic classes Antisense Oligonucleotide [EPC], Decreased RNA Integrity [PE], Increased Protein Breakdown [PE], Oligonucleotides, Antisense [CS], Transthyretin-directed RNA Interaction [EPC]
NDC exclude flag No
Listing certified through 2024-12-31
Current FDA listing Historical FDA.report record 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 N211172-001 TEGSEDI INOTERSEN SODIUM EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD 2018-10-05
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211172-001 8697860 2031-04-29 Drug product 2018-11-01 N211172-001 9061044 2031-04-29 Drug substance 2018-11-01 N211172-001 9399774 2031-04-29 U-2430 2018-11-01
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 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD 2018-10-05 c2088c7a36db…2026-09-14 22:38:34 2026-08 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD 2018-10-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD 2018-10-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD 2018-10-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD 2018-10-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD 2018-10-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD 2018-10-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD 2018-10-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD 2018-10-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD 2018-10-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD 2018-10-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD 2018-10-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211172-001 TEGSEDI EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2018-10-05 3a93d1ddd44b…
Observed Orange Book patent history# Patent history page 1 of 6 · 219 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 N211172-001 8697860 2031-04-29 Drug product 2018-11-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211172-001 9061044 2031-04-29 Drug substance 2018-11-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211172-001 9399774 2031-04-29 U-2430 2018-11-01 c2088c7a36db…2026-09-14 22:38:34 2026-08 N211172-001 8697860 2031-04-29 Drug product 2018-11-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211172-001 9061044 2031-04-29 Drug substance 2018-11-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211172-001 9399774 2031-04-29 U-2430 2018-11-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211172-001 8697860 2031-04-29 Drug product 2018-11-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211172-001 9061044 2031-04-29 Drug substance 2018-11-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211172-001 9399774 2031-04-29 U-2430 2018-11-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211172-001 8697860 2031-04-29 Drug product 2018-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211172-001 9061044 2031-04-29 Drug substance 2018-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211172-001 9399774 2031-04-29 U-2430 2018-11-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211172-001 8101743 2025-04-01 Drug substance, Drug product 2018-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211172-001 8697860 2031-04-29 Drug product 2018-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211172-001 9061044 2031-04-29 Drug substance 2018-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211172-001 9399774 2031-04-29 U-2430 2018-11-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211172-001 8101743 2025-04-01 Drug substance, Drug product 2018-11-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211172-001 8697860 2031-04-29 Drug product 2018-11-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211172-001 9061044 2031-04-29 Drug substance 2018-11-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211172-001 9399774 2031-04-29 U-2430 2018-11-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211172-001 8101743 2025-04-01 Drug substance, Drug product 2018-11-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211172-001 8697860 2031-04-29 Drug product 2018-11-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211172-001 9061044 2031-04-29 Drug substance 2018-11-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211172-001 9399774 2031-04-29 U-2430 2018-11-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211172-001 8101743 2025-04-01 Drug substance, Drug product 2018-11-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211172-001 8697860 2031-04-29 Drug product 2018-11-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211172-001 9061044 2031-04-29 Drug substance 2018-11-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211172-001 9399774 2031-04-29 U-2430 2018-11-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211172-001 8101743 2025-04-01 Drug substance, Drug product 2018-11-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211172-001 8697860 2031-04-29 Drug product 2018-11-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211172-001 9061044 2031-04-29 Drug substance 2018-11-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211172-001 9399774 2031-04-29 U-2430 2018-11-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211172-001 8101743 2025-04-01 Drug substance, Drug product 2018-11-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211172-001 8697860 2031-04-29 Drug product 2018-11-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211172-001 9061044 2031-04-29 Drug substance 2018-11-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211172-001 9399774 2031-04-29 U-2430 2018-11-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211172-001 8101743 2025-04-01 Drug substance, Drug product 2018-11-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211172-001 8697860 2031-04-29 Drug product 2018-11-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211172-001 9061044 2031-04-29 Drug substance 2018-11-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211172-001 9399774 2031-04-29 U-2430 2018-11-01 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 63 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 72126-007-01 Tegsedi 4 in 1 CARTON INJECTION, SOLUTION 4 10 72126-007-02 Tegsedi 1.5 mL in 1 SYRINGE INJECTION, SOLUTION 1.5 10 72126-007-02 Tegsedi 1 in 1 TRAY INJECTION, SOLUTION 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72126-007 TEGSEDI (INOTERSEN) INJECTION, SOLUTION [AKCEA THERAPEUTICS, INC.] 10 Legacy NDC, 3 package rows 20240126_8513207e-b55f-417b-9473-af785146a543.zip
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 72126-007-01 72126000701 4 TRAY in 1 CARTON (72126-007-01) > 1 SYRINGE in 1 TRAY (72126-007-02) > 1.5 mL in 1 SYRINGE 4 tray 2018-10-05 0000-00-00 No No Current