FDA.reportPublic FDA data

Liothyronine sodium

Product NDC
71335-1978
11-digit product format
713351978
Labeler code
71335
Product ID
71335-1978_a1e6ccd8-3ee9-44b0-8d8f-d4360cb9759a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Liothyronine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214803
Marketing category
ANDA
Marketing start
2021-02-01
Substance
LIOTHYRONINE SODIUM
Active strength
50 ug/1
Pharmacologic classes
Triiodothyronine [CS], l-Triiodothyronine [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Liothyronine sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIOTHYRONINE SODIUM50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGCA9VV7D2N
Rxcui903703

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b42496cd-a994-8ba1-597f-e507aa62246eProduct name520250116

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1978-12024-07-31C16284748780-11030e365-433e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LIOTHYRONINE SODIUM TABLETS safely and effectively. See full prescribing information for LIOTHYRONINE SODIUM TABLETS. LIOTHYRONINE SODIUM tablets, for oral use Initial U.S. Approval: 1956
71335-1978-12024-01-30C16284748780-11030e365-433e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LIOTHYRONINE SODIUM TABLETS safely and effectively. See full prescribing information for LIOTHYRONINE SODIUM TABLETS. LIOTHYRONINE SODIUM tablets, for oral use Initial U.S. Approval: 1956

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1978-1Liothyronine sodium30 in 1 BOTTLETABLET30103
71335-1978-2Liothyronine sodium90 in 1 BOTTLETABLET90103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1978LIOTHYRONINE SODIUM TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 2 package rows20240824_9d3633e3-44b7-4f62-9fe4-e5c7c4129345.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903703liothyronine sodium 50 MCG Oral TabletPSN9d3633e3-44b7-4f62-9fe4-e5c7c4129345103
903703liothyronine sodium 0.05 MG Oral TabletSCD9d3633e3-44b7-4f62-9fe4-e5c7c4129345103
903703liothyronine sodium 50 MCG Oral TabletSY9d3633e3-44b7-4f62-9fe4-e5c7c4129345103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1978-17133519780130 TABLET in 1 BOTTLE (71335-1978-1) 30 tablet2021-10-200000-00-00NoNoCurrent
71335-1978-27133519780290 TABLET in 1 BOTTLE (71335-1978-2) 90 tablet2024-08-12NoNoCurrent