FDA.reportPublic FDA data

Liothyronine sodium

Product NDC
68382-583
11-digit product format
683820583
Labeler code
68382
Product ID
68382-583_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
25 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 SODIUM25 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
68382-583-01Liothyronine sodium100 in 1 BOTTLETABLET1004
68382-583-10Liothyronine sodium1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-583-01EA - Each68382-583b7a5912c-ba98-4645-b851-6c1c6e2181e812021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-583LIOTHYRONINE 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
903697liothyronine sodium 25 MCG Oral TabletPSN5222f13d-7222-4845-b863-49e7558f5b1a102
903697liothyronine sodium 0.025 MG Oral TabletSCD5222f13d-7222-4845-b863-49e7558f5b1a102
903697liothyronine sodium 25 MCG Oral TabletSY5222f13d-7222-4845-b863-49e7558f5b1a102
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
68382-583-0168382058301100 TABLET in 1 BOTTLE (68382-583-01) 100 tablet2021-02-010000-00-00NoNoCurrent
68382-583-10683820583101000 TABLET in 1 BOTTLE (68382-583-10) 1000 tablet2021-02-010000-00-00NoNoCurrent