FDA.reportPublic FDA data

ORKAMBI

Product NDC
51167-900
11-digit product format
511670900
Labeler code
51167
Product ID
51167-900_e746b83a-cec1-40ab-8dba-7d8c1781e8b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lumacaftor and ivacaftor
Dosage form
GRANULE
Route
ORAL
Labeler
Vertex Pharmaceuticals Incorporated
Application
NDA211358
Marketing category
NDA
Marketing start
2018-08-07
Substance
IVACAFTOR; LUMACAFTOR
Active strength
125; 100 mg/1; mg/1
Pharmacologic classes
Chloride Channel Activation Potentiators [MoA], Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inducers [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IVACAFTOR125 mg/1
LUMACAFTOR100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEGP8L81APK, 1Y740ILL1Z
Rxcui1655928, 1655934, 1812468, 1812470, 2053509, 2053512, 2053517, 2053519, 2611458, 2611460

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
3345c65e-7c51-4ee3-a410-af7ec8592f92Product name220231010
31b21435-431d-4752-a7c5-89c6a41c6338Product name420230626
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51167-900-012024-01-30C16284748780-1e4f33bdf-a1fe-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ORKAMBI safely and effectively. See full prescribing information for ORKAMBI. ORKAMBI ® (lumacaftor and ivacaftor) tablets, for oral use ORKAMBI ® (lumacaftor and ivacaftor) oral granules Initial U.S. Approval: 2015
51167-900-012024-01-30C16284748780-1e4f33bdf-a1fe-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ORKAMBI safely and effectively. See full prescribing information for ORKAMBI. ORKAMBI ® (lumacaftor and ivacaftor) tablets, for oral use ORKAMBI ® (lumacaftor and ivacaftor) oral granules Initial U.S. Approval: 2015
51167-900-012024-01-30C16284748780-1e4f33bdf-a1fe-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ORKAMBI safely and effectively. See full prescribing information for ORKAMBI. ORKAMBI ® (lumacaftor and ivacaftor) tablets, for oral use ORKAMBI ® (lumacaftor and ivacaftor) oral granules Initial U.S. Approval: 2015
51167-900-012022-08-04C16284748780-1e4f33bdf-a1fe-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ORKAMBI safely and effectively. See full prescribing information for ORKAMBI. ORKAMBI ® (lumacaftor and ivacaftor) tablets, for oral use ORKAMBI ® (lumacaftor and ivacaftor) oral granules Initial U.S. Approval: 2015
51167-900-012022-08-04C16284748780-1e4f33bdf-a1fe-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ORKAMBI safely and effectively. See full prescribing information for ORKAMBI. ORKAMBI ® (lumacaftor and ivacaftor) tablets, for oral use ORKAMBI ® (lumacaftor and ivacaftor) oral granules Initial U.S. Approval: 2015
51167-900-012022-08-04C16284748780-1e4f33bdf-a1fe-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ORKAMBI safely and effectively. See full prescribing information for ORKAMBI. ORKAMBI ® (lumacaftor and ivacaftor) tablets, for oral use ORKAMBI ® (lumacaftor and ivacaftor) oral granules Initial U.S. Approval: 2015
51167-900-012022-07-29C16284748780-1e4f33bdf-a1fe-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ORKAMBI safely and effectively. See full prescribing information for ORKAMBI. ORKAMBI ® (lumacaftor and ivacaftor) tablets, for oral use ORKAMBI ® (lumacaftor and ivacaftor) oral granules Initial U.S. Approval: 2015
51167-900-012022-07-29C16284748780-1e4f33bdf-a1fe-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ORKAMBI safely and effectively. See full prescribing information for ORKAMBI. ORKAMBI ® (lumacaftor and ivacaftor) tablets, for oral use ORKAMBI ® (lumacaftor and ivacaftor) oral granules Initial U.S. Approval: 2015
51167-900-012022-07-29C16284748780-1e4f33bdf-a1fe-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ORKAMBI safely and effectively. See full prescribing information for ORKAMBI. ORKAMBI ® (lumacaftor and ivacaftor) tablets, for oral use ORKAMBI ® (lumacaftor and ivacaftor) oral granules Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51167-900-01ORKAMBI56 in 1 CARTONGRANULE5624
51167-900-01ORKAMBI1 in 1 PACKETGRANULE124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51167-900ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED ORKAMBI (LUMACAFTOR AND IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]21Current NDC, Legacy NDC, 2 package rows20241222_3fc1c40e-cfac-47a1-9e1a-61ead3570600.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2053509ivacaftor 125 MG / lumacaftor 100 MG Oral GranulesPSN3fc1c40e-cfac-47a1-9e1a-61ead357060024
2053517ivacaftor 188 MG / lumacaftor 150 MG Oral GranulesPSN3fc1c40e-cfac-47a1-9e1a-61ead357060024
2611458ivacaftor 94 MG / lumacaftor 75 MG Oral GranulesPSN3fc1c40e-cfac-47a1-9e1a-61ead357060024
1812468lumacaftor 100 MG / ivacaftor 125 MG Oral TabletPSN3fc1c40e-cfac-47a1-9e1a-61ead357060024
1655928lumacaftor 200 MG / ivacaftor 125 MG Oral TabletPSN3fc1c40e-cfac-47a1-9e1a-61ead357060024
2053512ORKAMBI 100 MG / 125 MG Oral GranulesPSN3fc1c40e-cfac-47a1-9e1a-61ead357060024
1812470ORKAMBI 100 MG / 125 MG Oral TabletPSN3fc1c40e-cfac-47a1-9e1a-61ead357060024
2053519ORKAMBI 150 MG / 188 MG Oral GranulesPSN3fc1c40e-cfac-47a1-9e1a-61ead357060024
1655934ORKAMBI 200 MG / 125 MG Oral TabletPSN3fc1c40e-cfac-47a1-9e1a-61ead357060024
2611460ORKAMBI 94 MG / 75 MG Oral GranulesPSN3fc1c40e-cfac-47a1-9e1a-61ead357060024
2053512ivacaftor 125 MG / lumacaftor 100 MG Oral Granules [ORKAMBI]SBD3fc1c40e-cfac-47a1-9e1a-61ead357060024
1812470ivacaftor 125 MG / lumacaftor 100 MG Oral Tablet [ORKAMBI]SBD3fc1c40e-cfac-47a1-9e1a-61ead357060024
1655934ivacaftor 125 MG / lumacaftor 200 MG Oral Tablet [ORKAMBI]SBD3fc1c40e-cfac-47a1-9e1a-61ead357060024
2053519ivacaftor 188 MG / lumacaftor 150 MG Oral Granules [ORKAMBI]SBD3fc1c40e-cfac-47a1-9e1a-61ead357060024
2611460ivacaftor 94 MG / lumacaftor 75 MG Oral Granules [ORKAMBI]SBD3fc1c40e-cfac-47a1-9e1a-61ead357060024
2053509ivacaftor 125 MG / lumacaftor 100 MG Oral GranulesSCD3fc1c40e-cfac-47a1-9e1a-61ead357060024
1812468ivacaftor 125 MG / lumacaftor 100 MG Oral TabletSCD3fc1c40e-cfac-47a1-9e1a-61ead357060024
1655928ivacaftor 125 MG / lumacaftor 200 MG Oral TabletSCD3fc1c40e-cfac-47a1-9e1a-61ead357060024
2053517ivacaftor 188 MG / lumacaftor 150 MG Oral GranulesSCD3fc1c40e-cfac-47a1-9e1a-61ead357060024
2611458ivacaftor 94 MG / lumacaftor 75 MG Oral GranulesSCD3fc1c40e-cfac-47a1-9e1a-61ead357060024
2053512ORKAMBI (ivacaftor 125 MG / lumacaftor 100 MG) Oral GranulesSY3fc1c40e-cfac-47a1-9e1a-61ead357060024
2053519ORKAMBI (ivacaftor 188 MG / lumacaftor 150 MG) Oral GranulesSY3fc1c40e-cfac-47a1-9e1a-61ead357060024
2611460ORKAMBI (ivacaftor 94 MG / lumacaftor 75 MG) Oral GranulesSY3fc1c40e-cfac-47a1-9e1a-61ead357060024
1812470ORKAMBI (lumacaftor 100 MG / ivacaftor 125 MG) Oral TabletSY3fc1c40e-cfac-47a1-9e1a-61ead357060024
1655934ORKAMBI (lumacaftor 200 MG / ivacaftor 125 MG) Oral TabletSY3fc1c40e-cfac-47a1-9e1a-61ead357060024

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51167-900-015116709000156 PACKET in 1 CARTON (51167-900-01) / 1 GRANULE in 1 PACKET56 packet2018-08-070000-00-00NoNoCurrent