FDA.reportPublic FDA data

SYMDEKO

Product NDC
51167-661
11-digit product format
511670661
Labeler code
51167
Product ID
51167-661_6ec7a22b-ccd3-408e-9564-bf8b8278da39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tezacaftor and Ivacaftor
Dosage form
KIT
Labeler
Vertex Pharmaceuticals Incorporated
Application
NDA210491
Marketing category
NDA
Marketing start
2018-02-12
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1243046, 1999387, 1999388, 1999389, 2174387, 2174388, 2174389, 2174390

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
29f82424-66ff-4356-862a-3564547225eaProduct name120250819
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
51167-661-012024-01-30C16284748780-11030e365-1073-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SYMDEKO safely and effectively. See full prescribing information for SYMDEKO. SYMDEKO ® (tezacaftor/ivacaftor) tablets; (ivacaftor) tablets, for oral use Initial U.S. Approval: 2018
51167-661-012024-01-30C16284748780-11030e365-1073-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SYMDEKO safely and effectively. See full prescribing information for SYMDEKO. SYMDEKO ® (tezacaftor/ivacaftor) tablets; (ivacaftor) tablets, for oral use Initial U.S. Approval: 2018
51167-661-012024-01-30C16284748780-11030e365-1073-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SYMDEKO safely and effectively. See full prescribing information for SYMDEKO. SYMDEKO ® (tezacaftor/ivacaftor) tablets; (ivacaftor) tablets, for oral use Initial U.S. Approval: 2018

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51167-661-01SYMDEKO1 in 1 CARTONKIT121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51167-661SYMDEKO (TEZACAFTOR AND IVACAFTOR) KIT [VERTEX PHARMACEUTICALS INCORPORATED]19Current NDC, Legacy NDC, 1 package rows20250227_302ae804-37db-44fd-ac2f-3dbdeda9aa4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1999389{28 (ivacaftor 150 MG / tezacaftor 100 MG Oral Tablet) / 28 (ivacaftor 150 MG Oral Tablet) } Pack [Symdeko (100 MG / 150 MG; 150 MG)]BPCK302ae804-37db-44fd-ac2f-3dbdeda9aa4b21
2174390{28 (ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet) / 28 (ivacaftor 75 MG Oral Tablet) } Pack [Symdeko (50 MG / 75 MG; 75 MG)]BPCK302ae804-37db-44fd-ac2f-3dbdeda9aa4b21
1999388{28 (ivacaftor 150 MG / tezacaftor 100 MG Oral Tablet) / 28 (ivacaftor 150 MG Oral Tablet) } PackGPCK302ae804-37db-44fd-ac2f-3dbdeda9aa4b21
2174389{28 (ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet) / 28 (ivacaftor 75 MG Oral Tablet) } PackGPCK302ae804-37db-44fd-ac2f-3dbdeda9aa4b21
1999388ivacaftor 150 MG / tezacaftor 100 MG (28) Oral Tablet / ivacaftor 150 MG (28) Oral Tablet PackPSN302ae804-37db-44fd-ac2f-3dbdeda9aa4b21
1999387ivacaftor 150 MG / tezacaftor 100 MG Oral TabletPSN302ae804-37db-44fd-ac2f-3dbdeda9aa4b21
1243046ivacaftor 150 MG Oral TabletPSN302ae804-37db-44fd-ac2f-3dbdeda9aa4b21
2174389ivacaftor 75 MG / tezacaftor 50 MG (28) Oral Tablet / ivacaftor 75 MG (28) Oral Tablet PackPSN302ae804-37db-44fd-ac2f-3dbdeda9aa4b21
2174387ivacaftor 75 MG / tezacaftor 50 MG Oral TabletPSN302ae804-37db-44fd-ac2f-3dbdeda9aa4b21
2174388ivacaftor 75 MG Oral TabletPSN302ae804-37db-44fd-ac2f-3dbdeda9aa4b21
1999389symdeko 100 MG / 150 MG and 150 MG PackPSN302ae804-37db-44fd-ac2f-3dbdeda9aa4b21
2174390symdeko 50 MG / 75 MG and 75 MG PackPSN302ae804-37db-44fd-ac2f-3dbdeda9aa4b21
1999387ivacaftor 150 MG / tezacaftor 100 MG Oral TabletSCD302ae804-37db-44fd-ac2f-3dbdeda9aa4b21
1243046ivacaftor 150 MG Oral TabletSCD302ae804-37db-44fd-ac2f-3dbdeda9aa4b21
2174387ivacaftor 75 MG / tezacaftor 50 MG Oral TabletSCD302ae804-37db-44fd-ac2f-3dbdeda9aa4b21
2174388ivacaftor 75 MG Oral TabletSCD302ae804-37db-44fd-ac2f-3dbdeda9aa4b21
1999388ivacaftor 150 MG / tezacaftor 100 MG (28) Oral Tablet / ivacaftor 150 MG (28) Oral Tablet PackSY302ae804-37db-44fd-ac2f-3dbdeda9aa4b21
2174389ivacaftor 75 MG / tezacaftor 50 MG (28) Oral Tablet / ivacaftor 75 MG (28) Oral Tablet PackSY302ae804-37db-44fd-ac2f-3dbdeda9aa4b21
1999389symdeko 100 MG / 150 MG and 150 MG PackSY302ae804-37db-44fd-ac2f-3dbdeda9aa4b21
2174390symdeko 50 MG / 75 MG and 75 MG PackSY302ae804-37db-44fd-ac2f-3dbdeda9aa4b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51167-661-01511670661011 KIT in 1 CARTON (51167-661-01) * 7 TABLET, FILM COATED in 1 BLISTER PACK * 7 TABLET, FILM COATED in 1 BLISTER PACK1 kit2018-02-120000-00-00NoNoCurrent