FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
51079-445
11-digit product format
510790445
Labeler code
51079
Product ID
51079-445_3a864332-4c4d-08a5-e063-6294a90aaaff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA076187
Marketing category
ANDA
Marketing start
2007-02-26
Substance
LEVOTHYROXINE SODIUM
Active strength
150 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 SODIUM150 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui892246, 966220, 966221, 966222, 966224, 966225

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
6a33ec05-2ae2-45e5-ab82-2d94b3303923Product name120190709
93355a10-1c44-4c92-a11d-7d995e0200d9Product name120190219

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51079-445-01Levothyroxine Sodium1 in 1 BLISTER PACKTABLET112
51079-445-20Levothyroxine Sodium100 in 1 CARTONTABLET10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-445-01EA - Each51079-445135da788-7aa4-4aed-8e0f-98e60754daee12012-07-24
51079-445-20EA - Each51079-4452b9d0d24-651a-4fa7-8945-3b19da4fc43512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOTHYROXINE SODIUMACTIVE INGREDIENT9J765S329GLEVOTHYROXINE SODIUM TABLET [CARDINAL HEALTH]9
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOTHYROXINE SODIUM TABLET [CARDINAL HEALTH]9
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2ULEVOTHYROXINE SODIUM TABLET [CARDINAL HEALTH]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOTHYROXINE SODIUM TABLET [CARDINAL HEALTH]9
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVOTHYROXINE SODIUM TABLET [CARDINAL HEALTH]9
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLEVOTHYROXINE SODIUM TABLET [CARDINAL HEALTH]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLEVOTHYROXINE SODIUM TABLET [CARDINAL HEALTH]9
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLEVOTHYROXINE SODIUM TABLET [CARDINAL HEALTH]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALEVOTHYROXINE SODIUM TABLET [CARDINAL HEALTH]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVOTHYROXINE SODIUM TABLET [CARDINAL HEALTH]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOTHYROXINE SODIUM TABLET [CARDINAL HEALTH]9
MANNITOLINACTIVE INGREDIENT3OWL53L36ALEVOTHYROXINE SODIUM TABLET [CARDINAL HEALTH]9
POVIDONESINACTIVE INGREDIENTFZ989GH94ELEVOTHYROXINE SODIUM TABLET [CARDINAL HEALTH]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOTHYROXINE SODIUM TABLET [CARDINAL HEALTH]9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLEVOTHYROXINE SODIUM TABLET [CARDINAL HEALTH]9
SUCROSEINACTIVE INGREDIENTC151H8M554LEVOTHYROXINE SODIUM TABLET [CARDINAL HEALTH]9
LEVOTHYROXINE SODIUMACTIVE INGREDIENT9J765S329GLEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2ULEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ALEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ELEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554LEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-445LEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]11Current NDC, Legacy NDC, 2 package rows20241012_5723c7a7-2a1d-4ab6-bf39-b2165ae781a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892246levothyroxine sodium 100 MCG Oral TabletPSN66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf24
966224levothyroxine sodium 125 MCG Oral TabletPSN66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf24
966225levothyroxine sodium 150 MCG Oral TabletPSN66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf24
966220levothyroxine sodium 25 MCG Oral TabletPSN66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf24
966221levothyroxine sodium 50 MCG Oral TabletPSN66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf24
966222levothyroxine sodium 75 MCG Oral TabletPSN66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf24
966220levothyroxine sodium 0.025 MG Oral TabletSCD66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf24
966221levothyroxine sodium 0.05 MG Oral TabletSCD66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf24
966222levothyroxine sodium 0.075 MG Oral TabletSCD66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf24
892246levothyroxine sodium 0.1 MG Oral TabletSCD66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf24
966224levothyroxine sodium 0.125 MG Oral TabletSCD66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf24
966225levothyroxine sodium 0.15 MG Oral TabletSCD66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf24
892246levothyroxine sodium 100 MCG Oral TabletSY66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf24
966224levothyroxine sodium 125 MCG Oral TabletSY66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf24
966225levothyroxine sodium 150 MCG Oral TabletSY66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf24
966220levothyroxine sodium 25 MCG Oral TabletSY66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf24
966221levothyroxine sodium 50 MCG Oral TabletSY66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf24
966222levothyroxine sodium 75 MCG Oral TabletSY66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf24
892246levothyroxine sodium 100 MCG Oral TabletPSN5723c7a7-2a1d-4ab6-bf39-b2165ae781a612
966224levothyroxine sodium 125 MCG Oral TabletPSN5723c7a7-2a1d-4ab6-bf39-b2165ae781a612
966225levothyroxine sodium 150 MCG Oral TabletPSN5723c7a7-2a1d-4ab6-bf39-b2165ae781a612
966220levothyroxine sodium 25 MCG Oral TabletPSN5723c7a7-2a1d-4ab6-bf39-b2165ae781a612
966221levothyroxine sodium 50 MCG Oral TabletPSN5723c7a7-2a1d-4ab6-bf39-b2165ae781a612
966222levothyroxine sodium 75 MCG Oral TabletPSN5723c7a7-2a1d-4ab6-bf39-b2165ae781a612
966220levothyroxine sodium 0.025 MG Oral TabletSCD5723c7a7-2a1d-4ab6-bf39-b2165ae781a612
966221levothyroxine sodium 0.05 MG Oral TabletSCD5723c7a7-2a1d-4ab6-bf39-b2165ae781a612
966222levothyroxine sodium 0.075 MG Oral TabletSCD5723c7a7-2a1d-4ab6-bf39-b2165ae781a612
892246levothyroxine sodium 0.1 MG Oral TabletSCD5723c7a7-2a1d-4ab6-bf39-b2165ae781a612
966224levothyroxine sodium 0.125 MG Oral TabletSCD5723c7a7-2a1d-4ab6-bf39-b2165ae781a612
966225levothyroxine sodium 0.15 MG Oral TabletSCD5723c7a7-2a1d-4ab6-bf39-b2165ae781a612
892246levothyroxine sodium 100 MCG Oral TabletSY5723c7a7-2a1d-4ab6-bf39-b2165ae781a612
966224levothyroxine sodium 125 MCG Oral TabletSY5723c7a7-2a1d-4ab6-bf39-b2165ae781a612
966225levothyroxine sodium 150 MCG Oral TabletSY5723c7a7-2a1d-4ab6-bf39-b2165ae781a612
966220levothyroxine sodium 25 MCG Oral TabletSY5723c7a7-2a1d-4ab6-bf39-b2165ae781a612
966221levothyroxine sodium 50 MCG Oral TabletSY5723c7a7-2a1d-4ab6-bf39-b2165ae781a612
966222levothyroxine sodium 75 MCG Oral TabletSY5723c7a7-2a1d-4ab6-bf39-b2165ae781a612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-445-01510790445011 in 1 BLISTER PACKHistorical
51079-445-2051079044520100 BLISTER PACK in 1 CARTON (51079-445-20) / 1 TABLET in 1 BLISTER PACK (51079-445-01) 100 blister pack2007-02-260000-00-00NoNoCurrent