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 44 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, UBIDECARENONUM, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, MELATONIN, PYRROLE, TRYPTOPHAN, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUSDeseret Biologicals, Inc.f267fff4-f331-49b8-bd48-7d383da522462023-01-11WarningsExact identifier
unii: ETJ7Z6XBU4
DALEKTRO NSILVER NITRATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, COBALTOUS NITRATE HEXAHYDRATE, CUPRIC ACETATE, IRON, POTASSIUM CARBONATE, MAGNESIUM CHLORIDE, MANGANESE ACETATE TETRAHYDRATE, SELENIUM, SILICON DIOXIDE, AND ZINC PHOSPHIDEPEKANA Natruheilmittel GmbH2b39ce30-54ff-4586-bda1-d9410140b26e2023-01-11WarningsExact identifier
unii: ETJ7Z6XBU4
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: ETJ7Z6XBU4
Chip CravingsCOUMARINUM, QUERCETIN, RUTIN, BAMBOO, BARLEY, POPPY SEED, CORN (ZEA MAYS), FLAX SEED (LINUM USITATISSIMUM), BUCKWHEAT (FAGOPYRUM ESULENTUM), MILLET, MILO, OAT, RICE, RYE, LENTILS, SESAME, AMARANTH, SOYBEAN, SUGARCANE (SACCHARUM OFFICINALE), SUNFLOWER SEED, WHEAT, AMARANTH, AVENA SATIVA, NATRUM SULPHURICUM, SARCOLACTICUM ACIDUM, TRITICUM REPENS, ADRENOCORTICOTROPHIN, SYCOTIC CO BACILLUSDr. Donna Restivo DC719ef104-88f3-4db5-9c3a-1ac9a1a63c262023-01-10WarningsExact identifier
unii: C151H8M554
SUPRENARSENIC TRIOXIDE, SULFURIC ACID, CHAMAELIRIUM LUTEUM ROOT, GOLDENSEAL, WOOD CREOSOTE, LEMNA MINOR, MAGNESIUM FLUORIDE, AND SILICON DIOXIDEPEKANA Naturheilmittel GmbH3b34740c-b181-4f05-9858-15b7211a4c672022-12-22WarningsExact identifier
unii: ETJ7Z6XBU4
KELANSILICON DIOXIDE, ARNICA MONTANA ROOT, GRAPHITE, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, MAGNESIUM FLUORIDE, MAGNESIUM SULFATE HEPTAHYDRATE, AND RUTA GRAVEOLENS FLOWERING TOPPEKANA Naturheilmittel GmbH55786d99-ee1f-490f-9023-3e6c39da86b02022-12-22WarningsExact identifier
unii: ETJ7Z6XBU4
COLIC CPAETHUSA CYNAPIUM, ALUMINUM OXIDE, BRYONIA ALBA ROOT, OYSTER SHELL CALCIUM CARBONATE CRUDE, MATRICARIA RECUTITA, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, ANEMONE PULSATILLA, SILICON DIOXIDE, SULFUR.Natural Creations, Inc.7c2a2f6e-a332-4c68-a7a8-fdc390f1827e2022-12-19WarningsExact identifier
unii: ETJ7Z6XBU4
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f0315c9e-8922-c0b5-e053-2a95a90ae54e2022-12-19WarningsExact identifier
unii: ETJ7Z6XBU4
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f031e256-fca5-3939-e053-2995a90a4fe62022-12-19WarningsExact identifier
unii: ETJ7Z6XBU4
SILICEASILICON DIOXIDEHyland's Inc.86da31ff-b39a-4ac2-92e5-810f6d8888e62022-12-19WarningsExact identifier
unii: ETJ7Z6XBU4
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f0328097-e5d2-3532-e053-2a95a90a93f02022-12-19WarningsExact identifier
unii: ETJ7Z6XBU4
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f032e7bb-a6fd-2951-e053-2a95a90a8c3a2022-12-19WarningsExact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEHyland's Inc.d3c426ab-1a61-3494-e053-2a95a90a96772022-12-14WarningsExact identifier
unii: ETJ7Z6XBU4
SiliceaSILICEAHahnemann Laboratories, INC.efcdc393-5dab-38d1-e053-2995a90acb2e2022-12-14Exact identifier
unii: ETJ7Z6XBU4
Defend Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PATENS, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.bb851be1-0528-4199-91e7-e09f994b28622022-12-12WarningsExact identifier
unii: ETJ7Z6XBU4
Miranda Castros healing cell salts for bones, hair, nails and teeth Homeopathic CombinationCALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEAOHM PHARMA INC.044a7174-f7a3-490f-9cad-01f2665d75752022-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
4 Kids Cold and Mucus NighttimeEUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFURHyland's Inc.6f7b2585-2f0e-5938-e053-2a91aa0aa9d12022-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
4 Kids Complete Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.ef39fe3d-a42d-4baa-9199-91f664feb4322022-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
Hendel Periodontal and Tooth Pain ReliefSODIUM BORATE, TRIBASIC CALCIUM PHOSPHATE, MERCURIUS SOLUBILIS, AND SILICON DIOXIDEMediNatura Incf34e9f77-69fd-4c7f-9eea-2d721a4d27fb2022-08-22WarningsExact identifier
unii: ETJ7Z6XBU4
Levothyroxine sodiumLEVOTHYROXINE SODIUMProficient Rx LP2f129a3d-f3e6-45b2-9704-3ad171cbd8a52022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966224
unii: 9J765S329G

Reported adverse events (FAERS/openFDA)#

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