FDA.reportPublic FDA data

LEVO-T

Product NDC
55466-104
11-digit product format
554660104
Labeler code
55466
Product ID
55466-104_1663d0cd-3e04-eecd-e063-6394a90ad90b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Neolpharma, Inc.
Application
NDA021342
Marketing category
NDA
Marketing start
2015-10-29
Substance
LEVOTHYROXINE SODIUM
Active strength
25 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
LEVO-T
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM25 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui892246, 892251, 892255, 966154, 966161, 966167, 966178, 966188, 966197, 966208, 966214, 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
6a33ec05-2ae2-45e5-ab82-2d94b3303923Product name120190709
93355a10-1c44-4c92-a11d-7d995e0200d9Product name120190219

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55466-104-11LEVO-T90 in 1 BOTTLETABLET9018
55466-104-19LEVO-T1000 in 1 BOTTLETABLET100018

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOTHYROXINE SODIUMACTIVE INGREDIENT9J765S329GLEVO-T (LEVOTHYROXINE SODIUM) TABLET [NEOLPHARMA, INC.]1
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVO-T (LEVOTHYROXINE SODIUM) TABLET [NEOLPHARMA, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVO-T (LEVOTHYROXINE SODIUM) TABLET [NEOLPHARMA, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVO-T (LEVOTHYROXINE SODIUM) TABLET [NEOLPHARMA, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVO-T (LEVOTHYROXINE SODIUM) TABLET [NEOLPHARMA, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LEVO-T (LEVOTHYROXINE SODIUM) TABLET [NEOLPHARMA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55466-104LEVO-T (LEVOTHYROXINE SODIUM) TABLET [NEOLPHARMA, INC.]18Current NDC, Legacy NDC, 2 package rows20240420_2085385a-7fe4-5bfe-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966178Levo-T 100 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
966397Levo-T 112 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
966188Levo-T 125 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
966410Levo-T 137 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
966197Levo-T 150 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
966399Levo-T 175 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
966208Levo-T 200 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
966154Levo-T 25 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
966214Levo-T 300 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
966161Levo-T 50 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
966167Levo-T 75 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
966401Levo-T 88 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
892246levothyroxine sodium 100 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
966248levothyroxine sodium 112 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
966224levothyroxine sodium 125 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
966270levothyroxine sodium 137 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
966225levothyroxine sodium 150 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
966249levothyroxine sodium 175 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
892251levothyroxine sodium 200 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
966220levothyroxine sodium 25 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
892255levothyroxine sodium 300 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
966221levothyroxine sodium 50 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
966222levothyroxine sodium 75 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
966253levothyroxine sodium 88 MCG Oral TabletPSN2085385a-7fe4-5bfe-e054-00144ff88e8818
966154levothyroxine sodium 0.025 MG Oral Tablet [Levo-T]SBD2085385a-7fe4-5bfe-e054-00144ff88e8818
966161levothyroxine sodium 0.05 MG Oral Tablet [Levo-T]SBD2085385a-7fe4-5bfe-e054-00144ff88e8818
966167levothyroxine sodium 0.075 MG Oral Tablet [Levo-T]SBD2085385a-7fe4-5bfe-e054-00144ff88e8818
966401levothyroxine sodium 0.088 MG Oral Tablet [Levo-T]SBD2085385a-7fe4-5bfe-e054-00144ff88e8818
966178levothyroxine sodium 0.1 MG Oral Tablet [Levo-T]SBD2085385a-7fe4-5bfe-e054-00144ff88e8818
966397levothyroxine sodium 0.112 MG Oral Tablet [Levo-T]SBD2085385a-7fe4-5bfe-e054-00144ff88e8818
966188levothyroxine sodium 0.125 MG Oral Tablet [Levo-T]SBD2085385a-7fe4-5bfe-e054-00144ff88e8818
966410levothyroxine sodium 0.137 MG Oral Tablet [Levo-T]SBD2085385a-7fe4-5bfe-e054-00144ff88e8818
966197levothyroxine sodium 0.15 MG Oral Tablet [Levo-T]SBD2085385a-7fe4-5bfe-e054-00144ff88e8818
966399levothyroxine sodium 0.175 MG Oral Tablet [Levo-T]SBD2085385a-7fe4-5bfe-e054-00144ff88e8818
966208levothyroxine sodium 0.2 MG Oral Tablet [Levo-T]SBD2085385a-7fe4-5bfe-e054-00144ff88e8818
966214levothyroxine sodium 0.3 MG Oral Tablet [Levo-T]SBD2085385a-7fe4-5bfe-e054-00144ff88e8818
966220levothyroxine sodium 0.025 MG Oral TabletSCD2085385a-7fe4-5bfe-e054-00144ff88e8818
966221levothyroxine sodium 0.05 MG Oral TabletSCD2085385a-7fe4-5bfe-e054-00144ff88e8818
966222levothyroxine sodium 0.075 MG Oral TabletSCD2085385a-7fe4-5bfe-e054-00144ff88e8818
966253levothyroxine sodium 0.088 MG Oral TabletSCD2085385a-7fe4-5bfe-e054-00144ff88e8818
892246levothyroxine sodium 0.1 MG Oral TabletSCD2085385a-7fe4-5bfe-e054-00144ff88e8818
966248levothyroxine sodium 0.112 MG Oral TabletSCD2085385a-7fe4-5bfe-e054-00144ff88e8818
966224levothyroxine sodium 0.125 MG Oral TabletSCD2085385a-7fe4-5bfe-e054-00144ff88e8818
966270levothyroxine sodium 0.137 MG Oral TabletSCD2085385a-7fe4-5bfe-e054-00144ff88e8818
966225levothyroxine sodium 0.15 MG Oral TabletSCD2085385a-7fe4-5bfe-e054-00144ff88e8818
966249levothyroxine sodium 0.175 MG Oral TabletSCD2085385a-7fe4-5bfe-e054-00144ff88e8818
892251levothyroxine sodium 0.2 MG Oral TabletSCD2085385a-7fe4-5bfe-e054-00144ff88e8818
892255levothyroxine sodium 0.3 MG Oral TabletSCD2085385a-7fe4-5bfe-e054-00144ff88e8818
966154Levo-T 0.025 MG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966161Levo-T 0.05 MG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966167Levo-T 0.075 MG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966401Levo-T 0.088 MG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966178Levo-T 0.1 MG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966397Levo-T 0.112 MG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966188Levo-T 0.125 MG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966410Levo-T 0.137 MG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966197Levo-T 0.15 MG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966399Levo-T 0.175 MG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966208Levo-T 0.2 MG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966214Levo-T 0.3 MG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966178Levo-T 100 MCG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966397Levo-T 112 MCG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966188Levo-T 125 MCG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966410Levo-T 137 MCG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966197Levo-T 150 MCG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966399Levo-T 175 MCG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966208Levo-T 200 MCG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966154Levo-T 25 MCG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966214Levo-T 300 MCG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966161Levo-T 50 MCG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966167Levo-T 75 MCG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966401Levo-T 88 MCG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
892246levothyroxine sodium 100 MCG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966248levothyroxine sodium 112 MCG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966224levothyroxine sodium 125 MCG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966270levothyroxine sodium 137 MCG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966225levothyroxine sodium 150 MCG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966249levothyroxine sodium 175 MCG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
892251levothyroxine sodium 200 MCG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818
966220levothyroxine sodium 25 MCG Oral TabletSY2085385a-7fe4-5bfe-e054-00144ff88e8818

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55466-104-115546601041190 TABLET in 1 BOTTLE (55466-104-11) 90 tablet2015-10-290000-00-00NoNoCurrent
55466-104-19554660104191000 TABLET in 1 BOTTLE (55466-104-19) 1000 tablet2018-08-070000-00-00NoNoCurrent