FDA.reportPublic FDA data

NDC 51167-545 - Trikafta

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
51167-545
Package NDCs from labels
51167-545-07
Manufacturer
Vertex Pharmaceuticals Incorporated | AndersonBrecon Inc. | Shanghai SynTheAll Pharmaceutical, Co., Ltd. | F.I.S. Fabbrica Italiana Sintetici S.P.A. | Pharmaceutical Manufacturing Research Services, Inc. | Almac Pharma Services LLC
Effective date
2026-06-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TrikaftaVertex Pharmaceuticals Incorporated | AndersonBrecon Inc. | Shanghai SynTheAll Pharmaceutical, Co., Ltd. | F.I.S. Fabbrica Italiana Sintetici S.P.A. | Pharmaceutical Manufacturing Research Services, Inc. | Almac Pharma Services LLC2026-06-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51167-545-07Trikafta1 in 1 PACKETGRANULE780 mg22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51167-545TRIKAFTA (ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR) KIT [VERTEX PHARMACEUTICALS INCORPORATED]20Unmatched20250215_f354423a-85c2-41c3-a9db-0f3aee135d8d.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 59 of 149 · 2,962 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral 40TITANIUM DIOXIDE, ZINC OXIDE2301 PLASTIC SURGERY, PLLC374d53a7-be0b-4d7a-e063-6394a90a37c42025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Mineral 40TITANIUM DIOXIDE, ZINC OXIDE2301 PLASTIC SURGERY, PLLC374df66d-eb9b-c4a7-e063-6394a90a3cc62025-12-11Exact identifier
unii: 15FIX9V2JP
Facial Mineral Sunscreen Mineral ProtectionTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.387f6dd5-3901-0849-e063-6294a90af8bc2025-12-11Exact identifier
unii: 15FIX9V2JP
Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELEDUC, XUANTO MD387e2e59-c5db-c70e-e063-6394a90a2d262025-12-11Exact identifier
unii: 15FIX9V2JP
Facial Mineral Sunscreen Mineral ProtectionTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.390779a8-4556-27a5-e063-6294a90a12002025-12-11Exact identifier
unii: 15FIX9V2JP
non-tinted sheer matte mineralTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35ba6cc9-0d49-6d0c-e063-6394a90ac7c32025-12-11Exact identifier
unii: 15FIX9V2JP
sheer tinted matte mineralTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35ba9ca7-fe5c-9824-e063-6394a90a5c462025-12-11Exact identifier
unii: 15FIX9V2JP
illuminating mineral mousseTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35bb4d67-373f-f60c-e063-6394a90a974d2025-12-11Exact identifier
unii: 15FIX9V2JP
Soft Focus Mineral Defense TintedTITANIUM DIOXIDE, ZINC OXIDESPOTLESS SKIN STUDIO387f1ea9-4764-3abe-e063-6394a90adde02025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352efbee-cab4-c515-e063-6294a90a46f22025-12-11Exact identifier
unii: 15FIX9V2JP
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELEDUC, XUANTO MD387e6e79-94db-dbb1-e063-6394a90aefd62025-12-11Exact identifier
unii: 15FIX9V2JP
Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352f5c53-3075-f437-e063-6394a90a4c4e2025-12-11Exact identifier
unii: 15FIX9V2JP
PreventionTITANIUM DIOXIDE, ZINC OXIDENoble Center for Healthy Aging LLC387dbf46-4316-a15d-e063-6394a90adeb12025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352f8de3-8ff0-4098-e063-6294a90ace4d2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incroporated35305bf1-8947-f275-e063-6294a90a30242025-12-11Exact identifier
unii: 15FIX9V2JP
DIZZINESS HPOYSTER SHELL CALCIUM CARBONATE CRUDE, CHENOPODIUM AMBROSIOIDES, ANAMIRTA COCCULUS SEED, CONIUM MACULATUM FLOWERING TOP, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, PULSATILLA VULGARIS, SILICON DIOXIDENatural Creations, Inc.9701096b-5efa-4acd-9227-339ecedfd6722025-12-10WarningsExact identifier
unii: ETJ7Z6XBU4
ProtectME Tinted Mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDEPUREFECTION LA, INC.33dccd5d-8db1-f699-e063-6394a90a59a22025-12-10Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Moisturizing SunscreenTITANIUM DIOXIDE, ZINC OXIDEABOUT FACE AESTHETICS, INC.364728b4-e0ff-8466-e063-6394a90a00892025-12-10Exact identifier
unii: 15FIX9V2JP
tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDESkin & Bare It LLC35d42661-e511-1dfc-e063-6294a90a9ed72025-12-10Exact identifier
unii: 15FIX9V2JP
non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDESkin & Bare It LLC35d3ef95-621c-f193-e063-6294a90ac3ee2025-12-10Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.