FDA.reportPublic FDA data

NDC 0378-1807-01 - Levothyroxine Sodium

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
0378-1807
Requested NDC
0378-1807-01
Package NDCs from labels
0378-1807-77, 0378-1807-10, 0378-1807-01
Manufacturer
Northwind Health Company, LLC
Effective date
2026-01-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levothyroxine Sodium - Northwind Health Company, LLCNorthwind Health Company, LLC2026-01-01HUMAN PRESCRIPTION DRUG LABEL
Levothyroxine Sodium - Mylan Institutional Inc.Mylan Institutional Inc.2025-07-23HUMAN PRESCRIPTION DRUG LABEL
Levothyroxine Sodium - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2024-04-15HUMAN PRESCRIPTION DRUG LABEL
Levothyroxine Sodium - Physicians Total Care, Inc.Physicians Total Care, Inc.2012-04-02HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-1807-10Levothyroxine Sodium1000 in 1 BOTTLE, PLASTICTABLET100031
0378-1807-77Levothyroxine Sodium90 in 1 BOTTLE, PLASTICTABLET9031

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-1807LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]31Legacy NDC, 2 package rows20240801_e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1807-01EA - Each0378-18078c51130c-7b0a-40c9-bd80-d8b8a6fc9f0912012-07-24
0378-1807-04EA - Each0378-1807ed56adb8-67a7-492d-a463-5dd63be7232412020-09-14
0378-1807-10EA - Each0378-180709d6916c-4da6-4807-99d4-6cfa7c41e05112012-07-24
0378-1807-77EA - Each0378-1807fd9ddea0-5ffd-4154-8ae7-f178279b633612016-07-19
0378-1807-95EA - Each0378-18072d1d14f5-e12f-4935-9f71-5cc43884887112020-09-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOTHYROXINE SODIUMACTIVE INGREDIENT9J765S329GLEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]6
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]6
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2ULEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]6
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KLEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]6
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BLEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]6
MANNITOLINACTIVE INGREDIENT3OWL53L36ALEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]6
POVIDONESINACTIVE INGREDIENTFZ989GH94ELEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]6
SUCROSEINACTIVE INGREDIENTC151H8M554LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]6
LEVOTHYROXINE SODIUMACTIVE INGREDIENT9J765S329GLEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]4
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]4
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2ULEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]4
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KLEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]4
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BLEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]4
MANNITOLINACTIVE INGREDIENT3OWL53L36ALEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]4
POVIDONEINACTIVE INGREDIENTFZ989GH94ELEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]4

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 43 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Silicea 6XSILICEA 6XTrue Botanica, LLCfd296871-c491-7d30-e053-6294a90ab64d2023-06-02WarningsExact identifier
unii: ETJ7Z6XBU4
Baby Nighttime Mucus Plus Cold ReliefCALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLAHyland's Inc.736b2487-e81d-d172-e053-2a91aa0ab0cf2023-04-17WarningsExact identifier
unii: ETJ7Z6XBU4
RadialginCITRUS LIMONUM, FUCUS VESICULOSUS, HYDRANGEA ARBORESCENS, SODIUM ALGINATE, NATRUM MURIATICUM, PHOSPHORUS, AGATE, RADIUM BROMATUM, X RAYNutritional Specialties, Inc.f1414ae2-4068-4076-bf11-b57a34ba5df22023-04-12WarningsExact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d34721-7dfc-bf91-e053-2991aa0a70ae2023-03-27Exact identifier
unii: ETJ7Z6XBU4
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
NS SupportBERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, CUPRUM ACETICUM, NADIDUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, AMMONIUM MURIATICUM, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS SUIS, PICRICUM ACIDUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, GNAPHALIUM POLYCEPHALUM,Dr. Donna Restivo DC807fd9cf-13d1-4173-a6da-180f89b67cf22023-03-15WarningsExact identifier
unii: ETJ7Z6XBU4
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUSDeseret Biologicals, Inc.d29af0e7-0d04-47e3-9a50-d99c7e14b44d2023-02-20WarningsExact identifier
unii: ETJ7Z6XBU4
Saccharum officinaleSUCROSEBoiron6858f374-8549-4b00-e053-2991aa0a5c3c2023-02-20Exact identifier
unii: C151H8M554
SiliceaSILICON DIOXIDEBoiron86d395ec-3c3b-5e5f-e053-2a91aa0a3f9c2023-02-20Exact identifier
unii: ETJ7Z6XBU4
EyeClear ProCALC CARB, CALC FLUOR, CAUSTICUM, CINERARIA, EUPHRASIA, NAPHTHALINUM, NAT MUR, PHOS, QUASSIA, SILICEASilver Star Brandsf4d4943b-cb78-aa71-e053-2a95a90ac6382023-02-16WarningsExact identifier
unii: ETJ7Z6XBU4
CellTropinARGININE, GINKGO BILOBA, HYPOPHYSIS SUIS, SILICEA, ASTRAGALUS EXCAPUSMicro Balance Health Products LLC502d3ffa-bbf4-403a-9fad-b6b229f36a8c2023-02-14WarningsExact identifier
unii: ETJ7Z6XBU4
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMXLCare Pharmaceuticals, Inc.51a27110-e787-409b-98ba-c6471d0ad5cf2023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966248
rxcui: 892251
rxcui: 966222
rxcui: 966270
rxcui: 892246
rxcui: 966221
rxcui: 892255
rxcui: 966224
rxcui: 966249
rxcui: 966220
rxcui: 966225
rxcui: 966253
unii: 9J765S329G
Saccharum OfficinaleSACCHARUM OFFICINALEHahnemann Laboratories, INC.f04b0ab3-af1c-ec2d-e053-2995a90a78552023-01-27Exact identifier
unii: C151H8M554
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMCamber Pharmaceuticals, Inc.b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e2023-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966248
rxcui: 892251
rxcui: 966222
rxcui: 966270
rxcui: 892246
rxcui: 966221
rxcui: 892255
rxcui: 966224
rxcui: 966249
rxcui: 966220
rxcui: 966225
rxcui: 966253
unii: 9J765S329G
SiliceaSILICON DIOXIDEBoiron86d2db09-9c46-37f7-e053-2a91aa0a326f2023-01-23Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3be33-b50e-e649-e053-2a91aa0acfc52023-01-23Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3be33-b4fb-e649-e053-2a91aa0acfc52023-01-23Exact identifier
unii: ETJ7Z6XBU4
Gyno ComplexVIBURNUM OPULUS, MAGNESIA PHOSPHORICA, FOLLICULINUM, PULSATILLA (PRATENSIS), BORAX, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, SILICEA, THUJA OCCIDENTALISDeseret Biologicals, Incdfaaa56a-4226-4f62-a219-d3f89fe7afe32023-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
Petrochemical DetoxCHELIDONIUM MAJUS, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SYMPHYTUM OFFICINALE, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, CADMIUM SULPHURATUM, GELSEMIUM SEMPERVIRENS, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PLATINUM METALLICUM, LATRODECTUS MACTANSDeseret Biologicals, Inc.b38b492a-cf45-4aa2-ba7e-4573d2c4ebe52023-01-12WarningsExact identifier
unii: 368GB5141J
SiliceaSILICON DIOXIDEBoiron86d367e5-e846-54ba-e053-2991aa0a63d42023-01-12Exact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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