FDA.reportPublic FDA data

levothyroxine sodium

Product NDC
71335-1478
11-digit product format
713351478
Labeler code
71335
Product ID
71335-1478_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
100 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 SODIUM100 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
71335-1478-0levothyroxine sodium1000 in 1 BOTTLETABLET100026
71335-1478-1levothyroxine sodium100 in 1 BOTTLETABLET10026
71335-1478-2levothyroxine sodium30 in 1 BOTTLETABLET3026
71335-1478-3levothyroxine sodium60 in 1 BOTTLETABLET6026
71335-1478-4levothyroxine sodium7 in 1 BOTTLETABLET726
71335-1478-5levothyroxine sodium14 in 1 BOTTLETABLET1426
71335-1478-6levothyroxine sodium90 in 1 BOTTLETABLET9026
71335-1478-7levothyroxine sodium28 in 1 BOTTLETABLET2826
71335-1478-8levothyroxine sodium56 in 1 BOTTLETABLET5626
71335-1478-9levothyroxine sodium180 in 1 BOTTLETABLET18026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1478-0EA - Each71335-1478e9696ef4-02c4-4c03-807f-3909a6bcdd6f12025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1478LEVOTHYROXINE SODIUM TABLET [BRYANT RANCH PREPACK]25Current NDC, Legacy NDC, 10 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
71335-1478-0713351478001000 TABLET in 1 BOTTLE (71335-1478-0) 1000 tablet2020-01-16NoNoHistorical
71335-1478-171335147801100 TABLET in 1 BOTTLE (71335-1478-1) 100 tablet2020-01-160000-00-00NoNoCurrent
71335-1478-27133514780230 TABLET in 1 BOTTLE (71335-1478-2) 30 tablet2020-01-160000-00-00NoNoCurrent
71335-1478-37133514780360 TABLET in 1 BOTTLE (71335-1478-3) 60 tablet2020-01-160000-00-00NoNoCurrent
71335-1478-4713351478047 TABLET in 1 BOTTLE (71335-1478-4) 7 tablet2020-01-160000-00-00NoNoCurrent
71335-1478-57133514780514 TABLET in 1 BOTTLE (71335-1478-5) 14 tablet2020-01-160000-00-00NoNoCurrent
71335-1478-67133514780690 TABLET in 1 BOTTLE (71335-1478-6) 90 tablet2020-01-160000-00-00NoNoCurrent
71335-1478-77133514780728 TABLET in 1 BOTTLE (71335-1478-7) 28 tablet2020-01-160000-00-00NoNoCurrent
71335-1478-87133514780856 TABLET in 1 BOTTLE (71335-1478-8) 56 tablet2020-01-160000-00-00NoNoCurrent
71335-1478-971335147809180 TABLET in 1 BOTTLE (71335-1478-9) 180 tablet2020-01-160000-00-00NoNoCurrent