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 109 of 149 · 2,962 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KIDS SPF30 SUPER SENSITIVE PLUS C111 SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY20ebe264-2f79-4eef-b83d-3f09a3ca28982024-11-06WarningsExact identifier
unii: 15FIX9V2JP
Cream Oil SunscreenZINC OXIDE, TITANIUM DIOXIDE SUNSCREENOwen Biosciences, Inc.b2ccdfea-1c27-42af-b9d8-752e9f91ae872024-11-05WarningsExact identifier
unii: 15FIX9V2JP
Sinus Congestion HeadacheANTIMONIUM TARTARICUM, ASAFOETIDA, BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, EUPHORBIA PILULIFERA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, IODIUM, KALI BICHROMICUM, LACHESIS MUTUS, MAGNESIA CARBONICA, MUCOSA NASALIS SUIS, PULSATILLA (PRATENSIS), PYROGENIUM, SILICEA, TEUCRIUM MARUMLiddell Laboratories, Inc.debc7747-8664-4598-a862-e295188c4fca2024-11-04WarningsExact identifier
unii: ETJ7Z6XBU4
VaccinesARNICA MONTANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MORBILLINUM, NATRUM MURIATICUM, SILICEA, SULPHUR IODATUM, THUJA OCCIDENTALIS, URTICA URENSLiddell Laboratories, Inc.6e6e67d4-089e-4775-b4a4-5511953f6e3f2024-11-04WarningsExact identifier
unii: ETJ7Z6XBU4
VaccistatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALUMINA, ANTIMONIUM TARTARICUM, MEZEREUM, NATRUM MURIATICUM, MERCURIUS SOLUBILIS, SILICEA, THUJA OCCIDENTALIS, MALANDRINUM, VARIOLINUMEnergique, Inc.8c8d63b6-763a-44f8-87ef-e83a89ec37762024-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
VaccistatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALUMINA, ANTIMONIUM TARTARICUM, MEZEREUM, NATRUM MURIATICUM, MERCURIUS SOLUBILIS, SILICEA, THUJA OCCIDENTALIS, MALANDRINUM, VARIOLINUMEnergique, Inc.5205cc3e-c9bc-48e9-9c9b-959a9be78b852024-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
AddiclenzBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.8a3b75ca-8fec-4318-8a55-8bde0b82637d2024-10-31WarningsExact identifier
unii: 15FIX9V2JP
SiliceaSILICEAEnergique, Inc.7ac17e38-d6e2-4cc9-8fcb-cbfa0d60223b2024-10-30WarningsExact identifier
unii: ETJ7Z6XBU4
ScarstatCALENDULA OFFICINALIS, GRAPHITES, HYPERICUM PERFORATUM, SILICEA, STAPHYSAGRIA, THIOSINAMINUMEnergique, Inc.1decc2eb-1261-46b8-908e-a152535b4a022024-10-30WarningsExact identifier
unii: ETJ7Z6XBU4
SILICEASILICEAEnergique, Inc.395f400d-6a87-4da9-aa1f-edca9729f1ac2024-10-30WarningsExact identifier
unii: ETJ7Z6XBU4
Scrophulous HPBARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, FERRUM IODATUM, GNAPHALIUM POLYCEPHALUM, MERCURIUS SOLUBILIS, PHYTOLACCA DECANDRA, RHUS TOX, SILICEAEnergique, Inc.e50eb26b-6843-4b8f-8ea5-3d5f57a3e7b42024-10-30WarningsExact identifier
unii: ETJ7Z6XBU4
ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEZO Skin Health, Inc.9a4f5be1-da04-48b9-897a-57f4a3d9d1ec2024-10-29WarningsExact identifier
unii: 15FIX9V2JP
ZO Skin Health Broad-Spectrum Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health, Inc.d817f80b-a998-b67e-e053-2995a90a19712024-10-29WarningsExact identifier
unii: 15FIX9V2JP
Chavita 1CARBO VEG, OOPHORINUM, SILICEA, OLIBANUM, ORCHITINUM, URTICA URENSRUBIMED AG0ade088f-0ff2-4894-9aed-d0b0cfdde38d2024-10-29WarningsExact identifier
unii: ETJ7Z6XBU4
PulmoparLOBELIA INFLATA, LUNG (SUIS), SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, BLATTA ORIENTALIS, BRYONIA (ALBA), PHOSPHORUS, SILICEA, SULPHUREnergique, Inc.1cfb69c5-dc01-4acc-8053-5ca4e64165dc2024-10-29WarningsExact identifier
unii: ETJ7Z6XBU4
Multi-Cell SaltKALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CALCAREA SULPHURICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, FERRUM PHOSPHORICUM, MAGNESIA PHOSPHORICA, SILICEAEnergique, Inc.dad00225-b3ac-4e36-a856-19b0faf42c422024-10-29WarningsExact identifier
unii: ETJ7Z6XBU4
Otoflam HPBELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SILICEA, CHAMOMILLA.Energique, Inc.76c6b494-43d1-4508-bea4-4f9026b4a5fa2024-10-29WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 30XSILICON DIOXIDETrue Botanica, LLC1d99c26a-3f95-c138-e063-6294a90a9d622024-10-28WarningsExact identifier
unii: ETJ7Z6XBU4
LymphastatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUMEnergique, Inc.ed3e0362-a4d3-46fa-a045-17bf659b777c2024-10-28WarningsExact identifier
unii: ETJ7Z6XBU4
HypothalmuparARALIA QUINQUEFOLIA, GINKGO BILOBA, HYDROCOTYLE ASIATICA, CEREBRUM SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, PHOSPHORUS, SILICEAEnergique, Inc.8b01e718-83b7-4f93-8fea-d0e37c7561852024-10-28WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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