Kalydeco

Product NDC
51167-200
11-digit product format
511670200
Labeler code
51167
Product ID
51167-200_13eb3fc2-0dac-4ada-96a8-a2e0cea711b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ivacaftor
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Vertex Pharmaceuticals Incorporated
Application
NDA203188
Marketing category
NDA
Marketing start
2012-01-31
Substance
IVACAFTOR
Active strength
150 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N203188-001KALYDECOIVACAFTOR150MGTABLET / ORALRLD, RS2012-01-31

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N203188-00183544272026-07-06U-13112015-01-26
N203188-00183544272026-07-06U-19052015-01-26
N203188-00184102742026-12-28Drug product2013-12-01
N203188-00187542242026-12-28Drug substance, Drug product2014-07-17
N203188-00196701632026-12-28U-1311Drug product2017-07-05
N203188-0018354427*PED2027-01-06Pediatric extension
N203188-00174951032027-05-20Drug substance, Drug product
N203188-0018410274*PED2027-06-28Pediatric extension
N203188-0018754224*PED2027-06-28Pediatric extension
N203188-0019670163*PED2027-06-28Pediatric extension
N203188-00183242422027-08-05U-13112013-01-03
N203188-00183242422027-08-05U-19062013-01-03
N203188-0017495103*PED2027-11-20Pediatric extension
N203188-0018324242*PED2028-02-05Pediatric extension
N203188-001106464812029-08-13Drug product2020-06-01
N203188-001115649162029-08-13U-35302023-02-28
N203188-001124586352029-08-13U-4339Drug product2025-11-26
N203188-00110646481*PED2030-02-13Pediatric extension
N203188-00111564916*PED2030-02-13Pediatric extension
N203188-00112458635*PED2030-02-13Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N203188-001ODE-3382027-12-21
N203188-001PED2028-06-21

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 · 46 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N203188-002KALYDECO75MGTABLET / ORALRLD2019-05-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-3187673890dc5c…
2021-03-12 10:30 UTC2021-03N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-313f01610625f2…
2019-12-14 00:12 UTC2019-12N203188-002KALYDECO75MGTABLET / ORALRLD2019-05-203f01610625f2…
2019-09-15 20:21 UTC2019-09N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-31b00525d2431f…
2019-09-15 20:21 UTC2019-09N203188-002KALYDECO75MGTABLET / ORALRLD2019-05-20b00525d2431f…
2019-07-19 19:46 UTC2019-07N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-31ea99ee380514…
2019-07-19 19:46 UTC2019-07N203188-002KALYDECO75MGTABLET / ORALRLD2019-05-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-313f0d92c62455…
2023-05-13 08:27 UTC2023-05N203188-001KALYDECO150MGTABLET / ORALRLD, RS2012-01-31053a50430f4f…

Observed Orange Book patent history#

Patent history page 1 of 13 · 492 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N203188-00183544272026-07-06U-19052015-01-26caaa826d4ba7…
2026-08-18 06:07:402026-07N203188-00183544272026-07-06U-13112015-01-26caaa826d4ba7…
2026-08-18 06:07:402026-07N203188-00184102742026-12-28Drug product2013-12-01caaa826d4ba7…
2026-08-18 06:07:402026-07N203188-00187542242026-12-28Drug substance, Drug product2014-07-17caaa826d4ba7…
2026-08-18 06:07:402026-07N203188-00196701632026-12-28U-1311Drug product2017-07-05caaa826d4ba7…
2026-08-18 06:07:402026-07N203188-0018354427*PED2027-01-06Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N203188-00174951032027-05-20Drug substance, Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N203188-0018410274*PED2027-06-28Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N203188-0018754224*PED2027-06-28Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N203188-0019670163*PED2027-06-28Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N203188-00183242422027-08-05U-13112013-01-03caaa826d4ba7…
2026-08-18 06:07:402026-07N203188-00183242422027-08-05U-19062013-01-03caaa826d4ba7…
2026-08-18 06:07:402026-07N203188-0017495103*PED2027-11-20Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N203188-0018324242*PED2028-02-05Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N203188-001106464812029-08-13Drug product2020-06-01caaa826d4ba7…
2026-08-18 06:07:402026-07N203188-001115649162029-08-13U-35302023-02-28caaa826d4ba7…
2026-08-18 06:07:402026-07N203188-001124586352029-08-13U-4339Drug product2025-11-26caaa826d4ba7…
2026-08-18 06:07:402026-07N203188-00110646481*PED2030-02-13Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N203188-00111564916*PED2030-02-13Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N203188-00112458635*PED2030-02-13Pediatric extensioncaaa826d4ba7…
2026-02-19 14:30 UTC2026-02N203188-00183544272026-07-06U-19052015-01-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203188-00183544272026-07-06U-13112015-01-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203188-00184102742026-12-28Drug product2013-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203188-00187542242026-12-28Drug substance, Drug product2014-07-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203188-00196701632026-12-28U-1311Drug product2017-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203188-0018354427*PED2027-01-06Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203188-00174951032027-05-20Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203188-0018410274*PED2027-06-28Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203188-0018754224*PED2027-06-28Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203188-0019670163*PED2027-06-28Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203188-00183242422027-08-05U-13112013-01-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203188-00183242422027-08-05U-19062013-01-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203188-0017495103*PED2027-11-20Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203188-0018324242*PED2028-02-05Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203188-001106464812029-08-13Drug product2020-06-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203188-001115649162029-08-13U-35302023-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203188-001124586352029-08-13U-4339Drug product2025-11-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203188-00110646481*PED2030-02-13Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203188-00111564916*PED2030-02-13Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203188-00112458635*PED2030-02-13Pediatric extension011fe1cb6892…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 201 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N203188-001ODE-3382027-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N203188-001PED2028-06-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N203188-001ODE-3382027-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203188-001PED2028-06-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203188-001ODE-1992025-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203188-001ODE-3382027-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203188-001PED2028-06-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N203188-001ODE-1992025-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203188-001ODE-3382027-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203188-001PED2028-06-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203188-001ODE-1992025-08-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203188-001ODE-3382027-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203188-001ODE-1992025-08-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203188-001ODE-3382027-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203188-001ODE-1902024-05-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203188-001ODE-1892024-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203188-001ODE-1992025-08-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203188-001ODE-3382027-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203188-001ODE-1902024-05-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203188-001ODE-1892024-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203188-001ODE-1992025-08-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203188-001ODE-3382027-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203188-001ODE-1902024-05-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203188-001ODE-1892024-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203188-001ODE-1992025-08-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203188-001ODE-3382027-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203188-001ODE-1902024-05-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203188-001ODE-1892024-07-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203188-001ODE-1992025-08-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203188-001ODE-3382027-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N203188-001ODE-1902024-05-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N203188-001ODE-1892024-07-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N203188-001ODE-1992025-08-15d06236e962d9…
2024-10-29 15:01 UTC2024-10N203188-001ODE-3382027-12-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203188-001ODE-1902024-05-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203188-001ODE-1892024-07-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203188-001ODE-1992025-08-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203188-001ODE-3382027-12-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203188-001ODE-1902024-05-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203188-001ODE-1892024-07-31301d65b070ca…

Additional Listing Data#

Finished product
Yes
Brand name base
Kalydeco
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IVACAFTOR150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1Y740ILL1ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1243046Internal RxNorm lookup
1243052Internal RxNorm lookup
1606862Internal RxNorm lookup
1606866Internal RxNorm lookup
1606868Internal RxNorm lookup
1606870Internal RxNorm lookup
2166399Internal RxNorm lookup
2166401Internal RxNorm lookup
2636787Internal RxNorm lookup
2636789Internal RxNorm lookup
2636791Internal RxNorm lookup
2636793Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe25Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
3345c65e-7c51-4ee3-a410-af7ec8592f92Product name220231010
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
31b21435-431d-4752-a7c5-89c6a41c6338Product name420230626
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
eaf14f5a-a483-45c2-b6bb-bda37f923e37Product name120180508
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
1c108d2a-865b-9f48-5b3a-b52233297e1dProduct name220150417
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
51167-200-01These highlights do not include all the information needed to use KALYDECO safely and effectively. See full prescribing information for KALYDECO. KALYDECO ® (ivacaftor) tablets, for oral use KALYDECO ® (ivacaftor) oral granules Initial U.S. Approval: 2012
51167-200-01These highlights do not include all the information needed to use KALYDECO safely and effectively. See full prescribing information for KALYDECO. KALYDECO ® (ivacaftor) tablets, for oral use KALYDECO ® (ivacaftor) oral granules Initial U.S. Approval: 2012
51167-200-01These highlights do not include all the information needed to use KALYDECO safely and effectively. See full prescribing information for KALYDECO. KALYDECO ® (ivacaftor) tablets, for oral use KALYDECO ® (ivacaftor) oral granules Initial U.S. Approval: 2012
51167-200-01These highlights do not include all the information needed to use KALYDECO safely and effectively. See full prescribing information for KALYDECO. KALYDECO ® (ivacaftor) tablets, for oral use KALYDECO ® (ivacaftor) oral granules Initial U.S. Approval: 2012
51167-200-02These highlights do not include all the information needed to use KALYDECO safely and effectively. See full prescribing information for KALYDECO. KALYDECO ® (ivacaftor) tablets, for oral use KALYDECO ® (ivacaftor) oral granules Initial U.S. Approval: 2012
51167-200-02These highlights do not include all the information needed to use KALYDECO safely and effectively. See full prescribing information for KALYDECO. KALYDECO ® (ivacaftor) tablets, for oral use KALYDECO ® (ivacaftor) oral granules Initial U.S. Approval: 2012
51167-200-02These highlights do not include all the information needed to use KALYDECO safely and effectively. See full prescribing information for KALYDECO. KALYDECO ® (ivacaftor) tablets, for oral use KALYDECO ® (ivacaftor) oral granules Initial U.S. Approval: 2012
51167-200-02These highlights do not include all the information needed to use KALYDECO safely and effectively. See full prescribing information for KALYDECO. KALYDECO ® (ivacaftor) tablets, for oral use KALYDECO ® (ivacaftor) oral granules Initial U.S. Approval: 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51167-200-01Kalydeco4 in 1 CARTONTABLET, FILM COATED436
51167-200-01Kalydeco14 in 1 BLISTER PACKTABLET, FILM COATED1436
51167-200-02Kalydeco1 in 1 CARTONTABLET, FILM COATED136
51167-200-02Kalydeco60 in 1 BOTTLETABLET, FILM COATED6036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51167-200-01EA - Each51167-200ba540eac-ebd4-4ec7-9fa3-53cf967c3f6812015-01-05
51167-200-02EA - Each51167-200bf9afa2e-82a3-44e6-b504-7989de35a89b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ivacaftorACTIVE INGREDIENT1Y740ILL1ZKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
ivacaftorACTIVE MOIETY1Y740ILL1ZKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
AMMONIAINACTIVE INGREDIENT5138Q19F1XKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)INACTIVE INGREDIENT6N003M473WKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
MANNITOLINACTIVE INGREDIENT3OWL53L36AKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
SHELLACINACTIVE INGREDIENT46N107B71OKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
TALCINACTIVE INGREDIENT7SEV7J4R1UKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51167-200KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]32Current NDC, Legacy NDC, 4 package rows20240628_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KalydecoIVACAFTORVertex Pharmaceuticals Incorporated0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe252026-03-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 203188
application number: NDA203188
ndc (product): 51167-200

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2636787ivacaftor 13.4 MG Oral GranulesPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1243046ivacaftor 150 MG Oral TabletPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2166399ivacaftor 25 MG Oral GranulesPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2636791ivacaftor 5.8 MG Oral GranulesPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1606862ivacaftor 50 MG Oral GranulesPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1606868ivacaftor 75 MG Oral GranulesPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2636789kalydeco 13.4 MG Oral GranulesPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1243052kalydeco 150 MG Oral TabletPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2166401kalydeco 25 MG Oral GranulesPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2636793kalydeco 5.8 MG Oral GranulesPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1606866kalydeco 50 MG Oral GranulesPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1606870kalydeco 75 MG Oral GranulesPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2636789ivacaftor 13.4 MG Oral Granules [Kalydeco]SBD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1243052ivacaftor 150 MG Oral Tablet [Kalydeco]SBD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2166401ivacaftor 25 MG Oral Granules [Kalydeco]SBD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2636793ivacaftor 5.8 MG Oral Granules [Kalydeco]SBD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1606866ivacaftor 50 MG Oral Granules [Kalydeco]SBD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1606870ivacaftor 75 MG Oral Granules [Kalydeco]SBD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2636787ivacaftor 13.4 MG Oral GranulesSCD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1243046ivacaftor 150 MG Oral TabletSCD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2166399ivacaftor 25 MG Oral GranulesSCD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2636791ivacaftor 5.8 MG Oral GranulesSCD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1606862ivacaftor 50 MG Oral GranulesSCD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1606868ivacaftor 75 MG Oral GranulesSCD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2636789Kalydeco 13.4 MG Oral GranulesSY0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1243052Kalydeco 150 MG Oral TabletSY0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2166401Kalydeco 25 MG Oral GranulesSY0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2636793Kalydeco 5.8 MG Oral GranulesSY0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1606866Kalydeco 50 MG Oral GranulesSY0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1606870Kalydeco 75 MG Oral GranulesSY0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51167-200-01511670200014 BLISTER PACK in 1 CARTON (51167-200-01) / 14 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack2012-01-310000-00-00NoNoCurrent
51167-200-02511670200021 BOTTLE in 1 CARTON (51167-200-02) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2012-01-310000-00-00NoNoCurrent