FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
0378-1811
11-digit product format
003781811
Labeler code
0378
Product ID
0378-1811_ca193039-55b1-4a7e-aa67-c4bff4f9f5b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA076187
Marketing category
ANDA
Marketing start
2002-11-01
Substance
LEVOTHYROXINE SODIUM
Active strength
112 ug/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levothyroxine Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM112 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui892246, 892251, 892255, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253, 966270

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
97c252d3-9bb8-4530-bb44-9824dc7cf556Product name620250729
6c43b71c-35e6-4db3-ba24-c6ef42ff7003Product name320240207
890fd4bf-1a80-42b7-be1b-2d0259d5f0c8Product name520240207
c8ad26bf-af73-460b-b74e-1eff16cc4f9fProduct name520240207
01383843-4069-43cf-aa76-dc17a6f9f8c4Product name220230123
978cca7d-a938-4791-8322-da48d90a63efProduct name120230113
65f86ba3-8816-4e12-899b-18290c8de551Product name220210614
f16ab90f-08c2-40be-a543-66d9827cd1f3Product name120210601
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
6a33ec05-2ae2-45e5-ab82-2d94b3303923Product name120190709
93355a10-1c44-4c92-a11d-7d995e0200d9Product name120190219
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-1811-10Levothyroxine Sodium1000 in 1 BOTTLE, PLASTICTABLET100031
0378-1811-77Levothyroxine Sodium90 in 1 BOTTLE, PLASTICTABLET9031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1811-01EA - Each0378-1811ff39899b-03b1-43e2-a366-d1ff6711d17812012-07-24
0378-1811-04EA - Each0378-181100ca6d82-a29c-4e6f-b8ee-f1c528dfa3f012020-09-14
0378-1811-10EA - Each0378-1811faeec880-706f-4fa1-9142-fcf119bda88b12012-07-24
0378-1811-77EA - Each0378-18115db691ec-696f-45fa-b0f9-4aba26b7499312016-07-19

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-1811LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]31Current NDC, Legacy NDC, 2 package rows20240801_e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892246levothyroxine sodium 100 MCG Oral TabletPSNe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966248levothyroxine sodium 112 MCG Oral TabletPSNe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966224levothyroxine sodium 125 MCG Oral TabletPSNe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966270levothyroxine sodium 137 MCG Oral TabletPSNe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966225levothyroxine sodium 150 MCG Oral TabletPSNe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966249levothyroxine sodium 175 MCG Oral TabletPSNe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
892251levothyroxine sodium 200 MCG Oral TabletPSNe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966220levothyroxine sodium 25 MCG Oral TabletPSNe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
892255levothyroxine sodium 300 MCG Oral TabletPSNe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966221levothyroxine sodium 50 MCG Oral TabletPSNe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966222levothyroxine sodium 75 MCG Oral TabletPSNe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966253levothyroxine sodium 88 MCG Oral TabletPSNe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966220levothyroxine sodium 0.025 MG Oral TabletSCDe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966221levothyroxine sodium 0.05 MG Oral TabletSCDe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966222levothyroxine sodium 0.075 MG Oral TabletSCDe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966253levothyroxine sodium 0.088 MG Oral TabletSCDe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
892246levothyroxine sodium 0.1 MG Oral TabletSCDe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966248levothyroxine sodium 0.112 MG Oral TabletSCDe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966224levothyroxine sodium 0.125 MG Oral TabletSCDe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966270levothyroxine sodium 0.137 MG Oral TabletSCDe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966225levothyroxine sodium 0.15 MG Oral TabletSCDe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966249levothyroxine sodium 0.175 MG Oral TabletSCDe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
892251levothyroxine sodium 0.2 MG Oral TabletSCDe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
892255levothyroxine sodium 0.3 MG Oral TabletSCDe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
892246levothyroxine sodium 100 MCG Oral TabletSYe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966248levothyroxine sodium 112 MCG Oral TabletSYe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966224levothyroxine sodium 125 MCG Oral TabletSYe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966270levothyroxine sodium 137 MCG Oral TabletSYe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966225levothyroxine sodium 150 MCG Oral TabletSYe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966249levothyroxine sodium 175 MCG Oral TabletSYe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
892251levothyroxine sodium 200 MCG Oral TabletSYe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966220levothyroxine sodium 25 MCG Oral TabletSYe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
892255levothyroxine sodium 300 MCG Oral TabletSYe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966221levothyroxine sodium 50 MCG Oral TabletSYe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966222levothyroxine sodium 75 MCG Oral TabletSYe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966253levothyroxine sodium 88 MCG Oral TabletSYe95720f2-91c9-a6d0-f7d5-8bcb94d07bbc31
966248levothyroxine sodium 112 MCG Oral TabletPSNcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11
966270levothyroxine sodium 137 MCG Oral TabletPSNcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11
966249levothyroxine sodium 175 MCG Oral TabletPSNcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11
966253levothyroxine sodium 88 MCG Oral TabletPSNcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11
966253levothyroxine sodium 0.088 MG Oral TabletSCDcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11
966248levothyroxine sodium 0.112 MG Oral TabletSCDcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11
966270levothyroxine sodium 0.137 MG Oral TabletSCDcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11
966249levothyroxine sodium 0.175 MG Oral TabletSCDcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11
966248levothyroxine sodium 112 MCG Oral TabletSYcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11
966270levothyroxine sodium 137 MCG Oral TabletSYcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11
966249levothyroxine sodium 175 MCG Oral TabletSYcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11
966253levothyroxine sodium 88 MCG Oral TabletSYcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11
892246levothyroxine sodium 100 MCG Oral TabletPSN40840f67-7066-4bb6-85c1-73eb2618cd264
966248levothyroxine sodium 112 MCG Oral TabletPSNdb10e666-6204-56cc-e053-2995a90a9e084
966248levothyroxine sodium 112 MCG Oral TabletPSN40840f67-7066-4bb6-85c1-73eb2618cd264
966220levothyroxine sodium 25 MCG Oral TabletPSN40840f67-7066-4bb6-85c1-73eb2618cd264
966221levothyroxine sodium 50 MCG Oral TabletPSN40840f67-7066-4bb6-85c1-73eb2618cd264
966222levothyroxine sodium 75 MCG Oral TabletPSN40840f67-7066-4bb6-85c1-73eb2618cd264
966253levothyroxine sodium 88 MCG Oral TabletPSN40840f67-7066-4bb6-85c1-73eb2618cd264
966220levothyroxine sodium 0.025 MG Oral TabletSCD40840f67-7066-4bb6-85c1-73eb2618cd264
966221levothyroxine sodium 0.05 MG Oral TabletSCD40840f67-7066-4bb6-85c1-73eb2618cd264
966222levothyroxine sodium 0.075 MG Oral TabletSCD40840f67-7066-4bb6-85c1-73eb2618cd264
966253levothyroxine sodium 0.088 MG Oral TabletSCD40840f67-7066-4bb6-85c1-73eb2618cd264
892246levothyroxine sodium 0.1 MG Oral TabletSCD40840f67-7066-4bb6-85c1-73eb2618cd264
966248levothyroxine sodium 0.112 MG Oral TabletSCD40840f67-7066-4bb6-85c1-73eb2618cd264
966248levothyroxine sodium 0.112 MG Oral TabletSCDdb10e666-6204-56cc-e053-2995a90a9e084
892246levothyroxine sodium 100 MCG Oral TabletSY40840f67-7066-4bb6-85c1-73eb2618cd264
966248levothyroxine sodium 112 MCG Oral TabletSY40840f67-7066-4bb6-85c1-73eb2618cd264
966248levothyroxine sodium 112 MCG Oral TabletSYdb10e666-6204-56cc-e053-2995a90a9e084
966220levothyroxine sodium 25 MCG Oral TabletSY40840f67-7066-4bb6-85c1-73eb2618cd264
966221levothyroxine sodium 50 MCG Oral TabletSY40840f67-7066-4bb6-85c1-73eb2618cd264
966222levothyroxine sodium 75 MCG Oral TabletSY40840f67-7066-4bb6-85c1-73eb2618cd264
966253levothyroxine sodium 88 MCG Oral TabletSY40840f67-7066-4bb6-85c1-73eb2618cd264

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-1811-04003781811041000 TABLET in 1 BOTTLE, PLASTIC (0378-1811-04) 1000 tablet2020-07-240000-00-00NoNoCurrent
0378-1811-10003781811101000 TABLET in 1 BOTTLE, PLASTIC (0378-1811-10) 1000 tablet2002-11-010000-00-00NoNoCurrent
0378-1811-770037818117790 TABLET in 1 BOTTLE, PLASTIC (0378-1811-77) 90 tablet2016-06-270000-00-00NoNoCurrent