Home DailyMed bf9afa2e-82a3-44e6-b504-7989de35a89b 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 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:35:40 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 43 .
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 N203188-001 KALYDECO IVACAFTOR 150MG TABLET / ORAL RLD, RS 2012-01-31
Orange Book patents# Current patent rows page 1 of 1 · 20 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203188-001 8354427 2026-07-06 U-1311 2015-01-26 N203188-001 8354427 2026-07-06 U-1905 2015-01-26 N203188-001 8410274 2026-12-28 Drug product 2013-12-01 N203188-001 8754224 2026-12-28 Drug substance, Drug product 2014-07-17 N203188-001 9670163 2026-12-28 U-1311 Drug product 2017-07-05 N203188-001 8354427*PED 2027-01-06 Pediatric extension N203188-001 7495103 2027-05-20 Drug substance, Drug product N203188-001 8410274*PED 2027-06-28 Pediatric extension N203188-001 8754224*PED 2027-06-28 Pediatric extension N203188-001 9670163*PED 2027-06-28 Pediatric extension N203188-001 8324242 2027-08-05 U-1311 2013-01-03 N203188-001 8324242 2027-08-05 U-1906 2013-01-03 N203188-001 7495103*PED 2027-11-20 Pediatric extension N203188-001 8324242*PED 2028-02-05 Pediatric extension N203188-001 10646481 2029-08-13 Drug product 2020-06-01 N203188-001 11564916 2029-08-13 U-3530 2023-02-28 N203188-001 12458635 2029-08-13 U-4339 Drug product 2025-11-26 N203188-001 10646481*PED 2030-02-13 Pediatric extension N203188-001 11564916*PED 2030-02-13 Pediatric extension N203188-001 12458635*PED 2030-02-13 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N203188-001 ODE-338 2027-12-21 N203188-001 PED 2028-06-21
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 · 47 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 2026-09-14 22:38:34 2026-08 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203188-002 KALYDECO 75MG TABLET / ORAL RLD 2019-05-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N203188-002 KALYDECO 75MG TABLET / ORAL RLD 2019-05-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N203188-002 KALYDECO 75MG TABLET / ORAL RLD 2019-05-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N203188-002 KALYDECO 75MG TABLET / ORAL RLD 2019-05-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203188-001 KALYDECO 150MG TABLET / ORAL RLD, RS 2012-01-31 3f0d92c62455…
Observed Orange Book patent history# Patent history page 1 of 13 · 512 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N203188-001 8354427 2026-07-06 U-1905 2015-01-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203188-001 8354427 2026-07-06 U-1311 2015-01-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203188-001 8410274 2026-12-28 Drug product 2013-12-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203188-001 8754224 2026-12-28 Drug substance, Drug product 2014-07-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203188-001 9670163 2026-12-28 U-1311 Drug product 2017-07-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203188-001 8354427*PED 2027-01-06 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203188-001 7495103 2027-05-20 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203188-001 8410274*PED 2027-06-28 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203188-001 8754224*PED 2027-06-28 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203188-001 9670163*PED 2027-06-28 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203188-001 8324242 2027-08-05 U-1311 2013-01-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203188-001 8324242 2027-08-05 U-1906 2013-01-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203188-001 7495103*PED 2027-11-20 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203188-001 8324242*PED 2028-02-05 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203188-001 10646481 2029-08-13 Drug product 2020-06-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203188-001 11564916 2029-08-13 U-3530 2023-02-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203188-001 12458635 2029-08-13 U-4339 Drug product 2025-11-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203188-001 10646481*PED 2030-02-13 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203188-001 11564916*PED 2030-02-13 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203188-001 12458635*PED 2030-02-13 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203188-001 8354427 2026-07-06 U-1905 2015-01-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203188-001 8354427 2026-07-06 U-1311 2015-01-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203188-001 8410274 2026-12-28 Drug product 2013-12-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203188-001 8754224 2026-12-28 Drug substance, Drug product 2014-07-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203188-001 9670163 2026-12-28 U-1311 Drug product 2017-07-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203188-001 8354427*PED 2027-01-06 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203188-001 7495103 2027-05-20 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203188-001 8410274*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203188-001 8754224*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203188-001 9670163*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203188-001 8324242 2027-08-05 U-1311 2013-01-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203188-001 8324242 2027-08-05 U-1906 2013-01-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203188-001 7495103*PED 2027-11-20 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203188-001 8324242*PED 2028-02-05 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203188-001 10646481 2029-08-13 Drug product 2020-06-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203188-001 11564916 2029-08-13 U-3530 2023-02-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203188-001 12458635 2029-08-13 U-4339 Drug product 2025-11-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203188-001 10646481*PED 2030-02-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203188-001 11564916*PED 2030-02-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203188-001 12458635*PED 2030-02-13 Pediatric extension caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 6 · 203 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.