Home DailyMed 774c7847-490b-41d5-9e0e-2baedbc94f62 Kynamro 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 Kastle Therapeutics, LLC | Genzyme Corporation | Genzyme Haverhill | International Laboratory Services, Ltd | Ionis Pharmaceuticals Inc. | PCI Pharma Services
Effective date 2017-01-17
Label type HUMAN PRESCRIPTION DRUG LABEL
Version 2
Source full-release
Hydrated at 2026-05-31 20:23:25 Label at a glance# Product Kynamro
Active ingredient MIPOMERSEN SODIUM
Label structure 2 sections
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY SPL version 1367848 Kynamro 200 MG in 1 ML Prefilled Syringe PSN 2 1367843 mipomersen sodium 200 MG in 1 ML Prefilled Syringe PSN 2 1367848 1 ML mipomersen sodium 200 MG/ML Prefilled Syringe [Kynamro] SBD 2 1367843 1 ML mipomersen sodium 200 MG/ML Prefilled Syringe SCD 2 1367848 1 ML Kynamro 200 MG/ML Prefilled Syringe SY 2 1367848 Kynamro 200 MG/ML 1 ML Prefilled Syringe SY 2 1367843 mipomersen sodium 200 MG per 1 ML Prefilled Syringe SY 2
DailyMed Pharmacologic Classes# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70688-0502-1 Kynamro 1 in 1 CARTON INJECTION, SOLUTION 1 2 70688-0502-1 Kynamro 1 mL in 1 SYRINGE INJECTION, SOLUTION 1 2 70688-0502-2 Kynamro 1 mL in 1 SYRINGE INJECTION, SOLUTION 1 2 70688-0502-2 Kynamro 4 in 1 CARTON INJECTION, SOLUTION 4 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70688-0502 KYNAMRO (MIPOMERSEN SODIUM) INJECTION, SOLUTION [KASTLE THERAPEUTICS, LLC] 2 Legacy NDC, 4 package rows 20170217_774c7847-490b-41d5-9e0e-2baedbc94f62.zip
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 6 matching rows.
Kynamro MIPOMERSEN SODIUM MIPOMERSEN WATER HYDROCHLORIC ACID SODIUM HYDROXIDE Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 4 matching rows.
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 N203568-001 KYNAMRO MIPOMERSEN SODIUM 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203568-001 7511131 2027-01-29 Drug substance
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 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 3a93d1ddd44b…
Observed Orange Book patent history# Patent history page 1 of 3 · 101 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 N203568-001 7511131 2027-01-29 Drug substance c2088c7a36db…2026-09-14 22:38:34 2026-08 N203568-001 7511131 2027-01-29 Drug substance 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203568-001 7511131 2027-01-29 Drug substance caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203568-001 7511131 2027-01-29 Drug substance 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203568-001 7511131 2027-01-29 Drug substance 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203568-001 7511131 2027-01-29 Drug substance 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203568-001 7511131 2027-01-29 Drug substance fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203568-001 7511131 2027-01-29 Drug substance b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203568-001 7511131 2027-01-29 Drug substance 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203568-001 7511131 2027-01-29 Drug substance 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203568-001 7511131 2027-01-29 Drug substance 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203568-001 7511131 2027-01-29 Drug substance d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203568-001 7511131 2027-01-29 Drug substance d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203568-001 7511131 2027-01-29 Drug substance 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203568-001 7511131 2027-01-29 Drug substance 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203568-001 7511131 2027-01-29 Drug substance 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203568-001 7511131 2027-01-29 Drug substance 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203568-001 7015315 2023-03-21 Drug substance 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203568-001 7101993 2023-09-05 Drug substance 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203568-001 7511131 2027-01-29 Drug substance 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203568-001 7015315 2023-03-21 Drug substance 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N203568-001 7101993 2023-09-05 Drug substance 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N203568-001 7511131 2027-01-29 Drug substance 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203568-001 7015315 2023-03-21 Drug substance 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N203568-001 7101993 2023-09-05 Drug substance 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N203568-001 7511131 2027-01-29 Drug substance 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203568-001 7407943 2021-08-01 U-1353 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203568-001 7015315 2023-03-21 Drug substance 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203568-001 7101993 2023-09-05 Drug substance 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203568-001 7511131 2027-01-29 Drug substance 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203568-001 7015315 2023-03-21 Drug substance bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N203568-001 7101993 2023-09-05 Drug substance bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N203568-001 7511131 2027-01-29 Drug substance bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203568-001 7407943 2021-08-01 U-1353 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N203568-001 7015315 2023-03-21 Drug substance 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N203568-001 7101993 2023-09-05 Drug substance 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N203568-001 7511131 2027-01-29 Drug substance 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203568-001 7407943 2021-08-01 U-1353 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203568-001 7015315 2023-03-21 Drug substance 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203568-001 7101993 2023-09-05 Drug substance 87673890dc5c…
Observed Orange Book exclusivity history# 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.
