FDA.reportPublic FDA data

levothyroxine sodium

Product NDC
71335-1435
11-digit product format
713351435
Labeler code
71335
Product ID
71335-1435_5dd258ee-53fd-4e60-b3c9-b3cfacd622bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA021116
Marketing category
NDA
Marketing start
2019-05-07
Substance
LEVOTHYROXINE SODIUM
Active strength
200 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 SODIUM200 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui892246, 892251, 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
71335-1435-1levothyroxine sodium100 in 1 BOTTLETABLET10026
71335-1435-2levothyroxine sodium30 in 1 BOTTLETABLET3026
71335-1435-3levothyroxine sodium90 in 1 BOTTLETABLET9026
71335-1435-4levothyroxine sodium60 in 1 BOTTLETABLET6026
71335-1435-5levothyroxine sodium18 in 1 BOTTLETABLET1826

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1435LEVOTHYROXINE SODIUM TABLET [BRYANT RANCH PREPACK]25Current NDC, Legacy NDC, 5 package rows20240830_9e3bffb9-f66e-4c73-befc-e60d769f6610.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892246levothyroxine sodium 100 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966248levothyroxine sodium 112 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966224levothyroxine sodium 125 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966270levothyroxine sodium 137 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966225levothyroxine sodium 150 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966249levothyroxine sodium 175 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
892251levothyroxine sodium 200 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966220levothyroxine sodium 25 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966221levothyroxine sodium 50 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966222levothyroxine sodium 75 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966253levothyroxine sodium 88 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966220levothyroxine sodium 0.025 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966221levothyroxine sodium 0.05 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966222levothyroxine sodium 0.075 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966253levothyroxine sodium 0.088 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
892246levothyroxine sodium 0.1 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966248levothyroxine sodium 0.112 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966224levothyroxine sodium 0.125 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966270levothyroxine sodium 0.137 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966225levothyroxine sodium 0.15 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966249levothyroxine sodium 0.175 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
892251levothyroxine sodium 0.2 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
892246levothyroxine sodium 100 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966248levothyroxine sodium 112 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966224levothyroxine sodium 125 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966270levothyroxine sodium 137 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966225levothyroxine sodium 150 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966249levothyroxine sodium 175 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
892251levothyroxine sodium 200 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966220levothyroxine sodium 25 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966221levothyroxine sodium 50 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966222levothyroxine sodium 75 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966253levothyroxine sodium 88 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1435-171335143501100 TABLET in 1 BOTTLE (71335-1435-1) 100 tablet2019-12-120000-00-00NoNoCurrent
71335-1435-27133514350230 TABLET in 1 BOTTLE (71335-1435-2) 30 tablet2019-12-120000-00-00NoNoCurrent
71335-1435-37133514350390 TABLET in 1 BOTTLE (71335-1435-3) 90 tablet2019-12-120000-00-00NoNoCurrent
71335-1435-47133514350460 TABLET in 1 BOTTLE (71335-1435-4) 60 tablet2019-12-120000-00-00NoNoCurrent
71335-1435-57133514350518 TABLET in 1 BOTTLE (71335-1435-5) 18 tablet2019-12-120000-00-00NoNoCurrent