FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
59651-554
11-digit product format
596510554
Labeler code
59651
Product ID
59651-554_c760d0cc-2245-4914-8c67-d536c41ac90f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA216414
Marketing category
ANDA
Marketing start
2024-07-16
Substance
LEVOTHYROXINE SODIUM
Active strength
137 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 SODIUM137 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui892251, 892255, 966225, 966249, 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
59651-554-90Levothyroxine Sodium90 in 1 BOTTLETABLET901
59651-554-99Levothyroxine Sodium1000 in 1 BOTTLETABLET10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-554LEVOTHYROXINE SODIUM TABLET [AUROBINDO PHARMA LIMITED]1Current NDC, 2 package rows20240724_c760d0cc-2245-4914-8c67-d536c41ac90f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966270levothyroxine sodium 137 MCG Oral TabletPSNc760d0cc-2245-4914-8c67-d536c41ac90f1
966225levothyroxine sodium 150 MCG Oral TabletPSNc760d0cc-2245-4914-8c67-d536c41ac90f1
966249levothyroxine sodium 175 MCG Oral TabletPSNc760d0cc-2245-4914-8c67-d536c41ac90f1
892251levothyroxine sodium 200 MCG Oral TabletPSNc760d0cc-2245-4914-8c67-d536c41ac90f1
892255levothyroxine sodium 300 MCG Oral TabletPSNc760d0cc-2245-4914-8c67-d536c41ac90f1
966270levothyroxine sodium 0.137 MG Oral TabletSCDc760d0cc-2245-4914-8c67-d536c41ac90f1
966225levothyroxine sodium 0.15 MG Oral TabletSCDc760d0cc-2245-4914-8c67-d536c41ac90f1
966249levothyroxine sodium 0.175 MG Oral TabletSCDc760d0cc-2245-4914-8c67-d536c41ac90f1
892251levothyroxine sodium 0.2 MG Oral TabletSCDc760d0cc-2245-4914-8c67-d536c41ac90f1
892255levothyroxine sodium 0.3 MG Oral TabletSCDc760d0cc-2245-4914-8c67-d536c41ac90f1
966270levothyroxine sodium 137 MCG Oral TabletSYc760d0cc-2245-4914-8c67-d536c41ac90f1
966225levothyroxine sodium 150 MCG Oral TabletSYc760d0cc-2245-4914-8c67-d536c41ac90f1
966249levothyroxine sodium 175 MCG Oral TabletSYc760d0cc-2245-4914-8c67-d536c41ac90f1
892251levothyroxine sodium 200 MCG Oral TabletSYc760d0cc-2245-4914-8c67-d536c41ac90f1
892255levothyroxine sodium 300 MCG Oral TabletSYc760d0cc-2245-4914-8c67-d536c41ac90f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-554-905965105549090 TABLET in 1 BOTTLE (59651-554-90) 90 tablet2024-07-16NoNoHistorical
59651-554-99596510554991000 TABLET in 1 BOTTLE (59651-554-99) 1000 tablet2024-07-16NoNoHistorical