FDA.reportPublic FDA data

Liothyronine sodium

Product NDC
68382-582
11-digit product format
683820582
Labeler code
68382
Product ID
68382-582_04696ad1-0a11-4e94-b4d2-c4b66d688b3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Liothyronine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA214803
Marketing category
ANDA
Marketing start
2021-02-01
Substance
LIOTHYRONINE SODIUM
Active strength
5 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 SODIUM5 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGCA9VV7D2N
Rxcui903456, 903697, 903703

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-582-01Liothyronine sodium100 in 1 BOTTLETABLET1004
68382-582-10Liothyronine sodium1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-582-01EA - Each68382-582fd1ebe2e-9127-4dea-86bd-1980fb1ff7cd12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-582LIOTHYRONINE SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]4Current NDC, Legacy NDC, 2 package rows20240814_c54cf95f-6465-4203-b98b-a54ba5a26843.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903456liothyronine sodium 5 MCG Oral TabletPSNb18e24fd-def0-4ff4-aa08-5f91c03c6f9e104
903456liothyronine sodium 0.005 MG Oral TabletSCDb18e24fd-def0-4ff4-aa08-5f91c03c6f9e104
903456liothyronine sodium 5 MCG Oral TabletSYb18e24fd-def0-4ff4-aa08-5f91c03c6f9e104
903456liothyronine sodium 5 MCG Oral TabletPSN52baac91-4b00-40d4-9ca7-8b9405bd415c6
903456liothyronine sodium 0.005 MG Oral TabletSCD52baac91-4b00-40d4-9ca7-8b9405bd415c6
903456liothyronine sodium 5 MCG Oral TabletSY52baac91-4b00-40d4-9ca7-8b9405bd415c6
903697liothyronine sodium 25 MCG Oral TabletPSNc54cf95f-6465-4203-b98b-a54ba5a268434
903456liothyronine sodium 5 MCG Oral TabletPSNc54cf95f-6465-4203-b98b-a54ba5a268434
903703liothyronine sodium 50 MCG Oral TabletPSNc54cf95f-6465-4203-b98b-a54ba5a268434
903456liothyronine sodium 0.005 MG Oral TabletSCDc54cf95f-6465-4203-b98b-a54ba5a268434
903697liothyronine sodium 0.025 MG Oral TabletSCDc54cf95f-6465-4203-b98b-a54ba5a268434
903703liothyronine sodium 0.05 MG Oral TabletSCDc54cf95f-6465-4203-b98b-a54ba5a268434
903697liothyronine sodium 25 MCG Oral TabletSYc54cf95f-6465-4203-b98b-a54ba5a268434
903456liothyronine sodium 5 MCG Oral TabletSYc54cf95f-6465-4203-b98b-a54ba5a268434
903703liothyronine sodium 50 MCG Oral TabletSYc54cf95f-6465-4203-b98b-a54ba5a268434

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-582-0168382058201100 TABLET in 1 BOTTLE (68382-582-01) 100 tablet2021-02-010000-00-00NoNoCurrent
68382-582-10683820582101000 TABLET in 1 BOTTLE (68382-582-10) 1000 tablet2021-02-010000-00-00NoNoCurrent