FDA.reportPublic FDA data

NDC 0378-1815-01 - 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
0378-1815
Requested NDC
0378-1815-01
Package NDCs from labels
0378-1815-77, 0378-1815-10, 0378-1815-01
Manufacturer
Mylan Institutional Inc.
Effective date
2025-07-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levothyroxine Sodium - Mylan Institutional Inc.Mylan Institutional Inc.2025-07-22HUMAN PRESCRIPTION DRUG LABEL
Levothyroxine Sodium - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2024-04-15HUMAN PRESCRIPTION DRUG LABEL
Levothyroxine Sodium - State of Florida DOH Central PharmacyState of Florida DOH Central Pharmacy2014-10-21HUMAN PRESCRIPTION DRUG LABEL
LEVOTHYROXINE SODIUM - Physicians Total Care, Inc.Physicians Total Care, Inc.2011-03-23HUMAN PRESCRIPTION DRUG LABEL
Levothyroxine Sodium - State of Florida DOH Central PharmacyState of Florida DOH Central Pharmacy2010-08-19HUMAN 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
0378-1815-10Levothyroxine Sodium1000 in 1 BOTTLE, PLASTICTABLET100031
0378-1815-77Levothyroxine Sodium90 in 1 BOTTLE, PLASTICTABLET9031

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-1815LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]31Current NDC, Legacy 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
0378-1815-01EA - Each0378-1815ac8debd6-80c2-4b03-9e97-e6968dd9bf3a12012-07-24
0378-1815-04EA - Each0378-181561914b43-e646-4263-9242-9e2c7106193812020-09-14
0378-1815-10EA - Each0378-18158b4b946c-655b-436d-aba1-735a19038cfc12012-07-24
0378-1815-77EA - Each0378-1815bc8d7bc4-0341-4f36-a2f1-eb83b35a781b12016-07-19

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
LEVOTHYROXINE SODIUMACTIVE INGREDIENT9J765S329GLEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2ULEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ALEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ELEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
SUCROSEINACTIVE INGREDIENTC151H8M554LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
LEVOTHYROXINE SODIUMACTIVE INGREDIENT9J765S329GLEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
LEVOTHYROXINE SODIUMACTIVE INGREDIENT9J765S329GLEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2ULEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2ULEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KLEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BLEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ALEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ALEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ELEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ELEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SUCROSEINACTIVE INGREDIENTC151H8M554LEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2

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 15 of 50 · 997 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childhood Vaccination Nosode Combination 9409CHILDHOOD VACCINATION NOSODE COMBINATIONProfessional Complementary Health Formulasa7a262f1-fe38-4e6b-aefa-f9e8a914f38e2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Pleurisy Drops 2047PLEURISY DROPSProfessional Complementary Health Formulasb046d33f-170b-4b59-aa58-7632db9694fd2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Creosote Combination 9254CREOSOTE COMBINATIONProfessional Complementary Health Formulas9248c4d5-75a5-4b52-b6b1-b2b8af8da8272026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Bridged Ring Combination 9311BRIDGED RING COMBINATIONProfessional Complementary Health Formulasb4033f70-d974-493d-8ded-eaa3240bdac52026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Cell Salt Combination 8013CELL SALT COMBINATIONProfessional Complementary Health Formulasb3a33345-3c3d-4f86-ae4d-757c65fd1ed32026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Substance Abuse Drops 2063SUBSTANCE ABUSE DROPSProfessional Complementary Health Formulas61f8263d-6f72-442f-a09e-57daf7226cc72026-01-08WarningsExact identifier
unii: C151H8M554
RET Heart 7009RET HEARTProfessional Complementary Health Formulase2bf8331-1c50-4216-93a4-1d3cf64047592026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Lumbar Drops 5013LUMBAR DROPSProfessional Complementary Health Formulasee6b54ea-fb6a-4723-8a0f-970aa82fea802026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Anti-Smoking I Drops 2007ANTI-SMOKING I DROPSProfessional Complementary Health Formulas1c6b5b98-971d-442a-b9eb-37f65409a5212026-01-08WarningsExact identifier
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Rehydration Drops 2175REHYDRATION DROPSProfessional Complementary Health Formulas58cc2bd1-c530-43bf-876e-f30d4d95b8da2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Dysfunctional Bleeding Drops 2138DYSFUNCTIONAL BLEEDING DROPSProfessional Complementary Health Formulas3e674c1e-c64b-416d-962f-c03493e800852026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Cervical Drops 5002CERVICAL DROPSProfessional Complementary Health Formulasedd5f196-1423-4d4c-a8c1-89427c4f387e2026-01-08WarningsExact identifier
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Asbestox 6005ASBESTOXProfessional Complementary Health Formulas90bc0d00-01e4-4134-809e-e216fd09852a2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Ledum Combination 9257LEDUM COMBINATIONProfessional Complementary Health Formulas38b89b32-4915-487d-8b2d-250123487b152026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Glucose Drops 2031GLUCOSE DROPSProfessional Complementary Health Formulas21de3b86-be2b-4f71-9384-78ebc42ec0872026-01-08WarningsExact identifier
unii: C151H8M554
Fourth Chakra (Heart) 7304FOURTH CHAKRA (HEART)Professional Complementary Health Formulasef061447-42ae-43d0-b6f3-bf19a96ffe922026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Spinal Drops 5025SPINAL DROPSProfessional Complementary Health Formulasca6d7250-9c9e-40a6-8d41-88aba33d21dd2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Anti-Scar Drops 2084ANTI-SCAR DROPSProfessional Complementary Health Formulasad0e9159-ed68-48aa-a7d1-7ff5c32ec3042026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Fifth Chakra (Throat) 7305FIFTH CHAKRA (THROAT)Professional Complementary Health Formulasb731f708-10a8-451f-8550-1e7302102b962026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Sixth Chakra (Third Eye) 7306SIXTH CHAKRA (THIRD EYE)Professional Complementary Health Formulas174024e7-e231-456c-bc00-48a358d7160a2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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