Home NDC 51167-785 Kalydeco
Product NDC 51167-785
11-digit product format 511670785
Labeler code 51167
Product ID 51167-785_13eb3fc2-0dac-4ada-96a8-a2e0cea711b7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ivacaftor
Dosage form GRANULE
Route ORAL
Labeler Vertex Pharmaceuticals Incorporated
Application NDA207925
Marketing category NDA
Marketing start 2023-05-03
Substance IVACAFTOR
Active strength 5.8 mg/1
Pharmacologic classes Chloride Channel Activation Potentiators [MoA], Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N207925-001 KALYDECO IVACAFTOR 50MG/PACKET GRANULE / ORAL RLD 2015-03-17 N207925-002 KALYDECO IVACAFTOR 75MG/PACKET GRANULE / ORAL RLD, RS 2015-03-17 N207925-003 KALYDECO IVACAFTOR 25MG/PACKET GRANULE / ORAL RLD 2019-04-29 N207925-004 KALYDECO IVACAFTOR 5.8MG/PACKET GRANULE / ORAL RLD 2023-05-03 N207925-005 KALYDECO IVACAFTOR 13.4MG/PACKET GRANULE / ORAL RLD 2023-05-03
Orange Book patents# Current patent rows page 1 of 2 · 155 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 30 matching rows.
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 5 · 172 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 2026-08-18 06:07:40 2026-07 N207925-001 KALYDECO 50MG/PACKET GRANULE / ORAL RLD 2015-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-002 KALYDECO 75MG/PACKET GRANULE / ORAL RLD, RS 2015-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-003 KALYDECO 25MG/PACKET GRANULE / ORAL RLD 2019-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-004 KALYDECO 5.8MG/PACKET GRANULE / ORAL RLD 2023-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-005 KALYDECO 13.4MG/PACKET GRANULE / ORAL RLD 2023-05-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207925-001 KALYDECO 50MG/PACKET GRANULE / ORAL RLD 2015-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207925-002 KALYDECO 75MG/PACKET GRANULE / ORAL RLD, RS 2015-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207925-003 KALYDECO 25MG/PACKET GRANULE / ORAL RLD 2019-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207925-004 KALYDECO 5.8MG/PACKET GRANULE / ORAL RLD 2023-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207925-005 KALYDECO 13.4MG/PACKET GRANULE / ORAL RLD 2023-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207925-001 KALYDECO 50MG/PACKET GRANULE / ORAL RLD 2015-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207925-002 KALYDECO 75MG/PACKET GRANULE / ORAL RLD, RS 2015-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207925-003 KALYDECO 25MG/PACKET GRANULE / ORAL RLD 2019-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207925-004 KALYDECO 5.8MG/PACKET GRANULE / ORAL RLD 2023-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207925-005 KALYDECO 13.4MG/PACKET GRANULE / ORAL RLD 2023-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207925-001 KALYDECO 50MG/PACKET GRANULE / ORAL RLD 2015-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207925-002 KALYDECO 75MG/PACKET GRANULE / ORAL RLD, RS 2015-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207925-003 KALYDECO 25MG/PACKET GRANULE / ORAL RLD 2019-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207925-004 KALYDECO 5.8MG/PACKET GRANULE / ORAL RLD 2023-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207925-005 KALYDECO 13.4MG/PACKET GRANULE / ORAL RLD 2023-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207925-001 KALYDECO 50MG/PACKET GRANULE / ORAL RLD 2015-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207925-002 KALYDECO 75MG/PACKET GRANULE / ORAL RLD, RS 2015-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207925-003 KALYDECO 25MG/PACKET GRANULE / ORAL RLD 2019-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207925-004 KALYDECO 5.8MG/PACKET GRANULE / ORAL RLD 2023-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207925-005 KALYDECO 13.4MG/PACKET GRANULE / ORAL RLD 2023-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207925-001 KALYDECO 50MG/PACKET GRANULE / ORAL RLD 2015-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207925-002 KALYDECO 75MG/PACKET GRANULE / ORAL RLD, RS 2015-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207925-003 KALYDECO 25MG/PACKET GRANULE / ORAL RLD 2019-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207925-004 KALYDECO 5.8MG/PACKET GRANULE / ORAL RLD 2023-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207925-005 KALYDECO 13.4MG/PACKET GRANULE / ORAL RLD 2023-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207925-001 KALYDECO 50MG/PACKET GRANULE / ORAL RLD 2015-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207925-002 KALYDECO 75MG/PACKET GRANULE / ORAL RLD, RS 2015-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207925-003 KALYDECO 25MG/PACKET GRANULE / ORAL RLD 2019-04-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207925-004 KALYDECO 5.8MG/PACKET GRANULE / ORAL RLD 2023-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207925-005 KALYDECO 13.4MG/PACKET GRANULE / ORAL RLD 2023-05-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207925-001 KALYDECO 50MG/PACKET GRANULE / ORAL RLD 2015-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207925-002 KALYDECO 75MG/PACKET GRANULE / ORAL RLD, RS 2015-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207925-003 KALYDECO 25MG/PACKET GRANULE / ORAL RLD 2019-04-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207925-004 KALYDECO 5.8MG/PACKET GRANULE / ORAL RLD 2023-05-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207925-005 KALYDECO 13.4MG/PACKET GRANULE / ORAL RLD 2023-05-03 2680178bc6a6…
Observed Orange Book patent history# Patent history page 1 of 81 · 3,229 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N207925-001 8354427 2026-07-06 U-1311 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8354427 2026-07-06 U-2528 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8354427 2026-07-06 U-1905 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8410274 2026-12-28 Drug product 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8754224 2026-12-28 Drug substance, Drug product 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 9670163 2026-12-28 U-1311 Drug product 2017-07-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 9670163 2026-12-28 U-2530 Drug product 2017-07-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8354427*PED 2027-01-06 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 7495103 2027-05-20 Drug substance, Drug product 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8410274*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8754224*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 9670163*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8324242 2027-08-05 U-1906 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8324242 2027-08-05 U-2527 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8324242 2027-08-05 U-1311 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 7495103*PED 2027-11-20 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8324242*PED 2028-02-05 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 10646481 2029-08-13 Drug product 2020-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 11564916 2029-08-13 U-3528 2023-02-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 12458635 2029-08-13 U-4337 Drug product 2025-11-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 10646481*PED 2030-02-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 11564916*PED 2030-02-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 12458635*PED 2030-02-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 10272046 2033-02-27 U-2531 Drug product 2019-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 11147770 2033-02-27 U-3339 Drug product 2022-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 11752106 2033-02-27 U-3697 Drug product 2023-10-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 12214083 2033-02-27 U-4126 Drug product 2025-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8883206 2033-02-27 Drug product 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 10272046*PED 2033-08-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 11147770*PED 2033-08-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 11752106*PED 2033-08-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 12214083*PED 2033-08-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-001 8883206*PED 2033-08-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-002 8354427 2026-07-06 U-1905 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-002 8354427 2026-07-06 U-2528 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-002 8354427 2026-07-06 U-1311 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-002 8410274 2026-12-28 Drug product 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-002 8754224 2026-12-28 Drug substance, Drug product 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-002 9670163 2026-12-28 U-2530 Drug product 2017-07-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207925-002 9670163 2026-12-28 U-1311 Drug product 2017-07-05 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 24 · 921 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Kalydeco
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IVACAFTOR 5.8 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1Y740ILL1Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 12 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1243046 Internal RxNorm lookup 1243052 Internal RxNorm lookup 1606862 Internal RxNorm lookup 1606866 Internal RxNorm lookup 1606868 Internal RxNorm lookup 1606870 Internal RxNorm lookup 2166399 Internal RxNorm lookup 2166401 Internal RxNorm lookup 2636787 Internal RxNorm lookup 2636789 Internal RxNorm lookup 2636791 Internal RxNorm lookup 2636793 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 51167-785-01 Kalydeco 56 in 1 CARTON GRANULE 56 36
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ivacaftor ACTIVE INGREDIENT 1Y740ILL1Z KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] 12 ivacaftor ACTIVE MOIETY 1Y740ILL1Z KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] 12 AMMONIA INACTIVE INGREDIENT 5138Q19F1X KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] 12 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] 12 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] 12 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] 12 FD&C Blue No. 2 INACTIVE INGREDIENT L06K8R7DQK KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] 12 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] 12 HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S) INACTIVE INGREDIENT 6N003M473W KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] 12 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] 12 MANNITOL INACTIVE INGREDIENT 3OWL53L36A KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] 12 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] 12 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] 12 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] 12 SHELLAC INACTIVE INGREDIENT 46N107B71O KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] 12 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] 12 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] 12 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] 12 TALC INACTIVE INGREDIENT 7SEV7J4R1U KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] 12 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51167-785 KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] 32 Current NDC, 1 package rows 20240628_0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe25.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51167-785-01 51167078501 56 GRANULE in 1 CARTON (51167-785-01) 56 granule 2023-05-03 No No Current