FDA.reportPublic FDA data

liothyronine sodium

Product NDC
62756-589
11-digit product format
627560589
Labeler code
62756
Product ID
62756-589_af12cd5c-3963-4ef2-b819-a42343f0cb69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
liothyronine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA091382
Marketing category
ANDA
Marketing start
2019-11-28
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62756-589-01liothyronine sodium90 in 1 BOTTLETABLET905
62756-589-08liothyronine sodium100 in 1 BOTTLETABLET1005
62756-589-18liothyronine sodium1000 in 1 BOTTLETABLET10005
62756-589-83liothyronine sodium30 in 1 BOTTLETABLET305
62756-589-88liothyronine sodium100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-589-88EA - Each62756-589fb40cc2c-7dc5-4671-a7d6-9f2afc7ca62712020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-589LIOTHYRONINE SODIUM TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]5Current NDC, Legacy NDC, 5 package rows20231004_892e63ef-3a60-45fa-b12b-d6795acc0956.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903697liothyronine sodium 25 MCG Oral TabletPSN892e63ef-3a60-45fa-b12b-d6795acc09565
903456liothyronine sodium 5 MCG Oral TabletPSN892e63ef-3a60-45fa-b12b-d6795acc09565
903703liothyronine sodium 50 MCG Oral TabletPSN892e63ef-3a60-45fa-b12b-d6795acc09565
903456liothyronine sodium 0.005 MG Oral TabletSCD892e63ef-3a60-45fa-b12b-d6795acc09565
903697liothyronine sodium 0.025 MG Oral TabletSCD892e63ef-3a60-45fa-b12b-d6795acc09565
903703liothyronine sodium 0.05 MG Oral TabletSCD892e63ef-3a60-45fa-b12b-d6795acc09565
903697liothyronine sodium 25 MCG Oral TabletSY892e63ef-3a60-45fa-b12b-d6795acc09565
903456liothyronine sodium 5 MCG Oral TabletSY892e63ef-3a60-45fa-b12b-d6795acc09565
903703liothyronine sodium 50 MCG Oral TabletSY892e63ef-3a60-45fa-b12b-d6795acc09565
903456liothyronine sodium 5 MCG Oral TabletPSN1d6b6f92-89e8-497a-ab23-d0afa2137d1f1
903456liothyronine sodium 0.005 MG Oral TabletSCD1d6b6f92-89e8-497a-ab23-d0afa2137d1f1
903456liothyronine sodium 5 MCG Oral TabletSY1d6b6f92-89e8-497a-ab23-d0afa2137d1f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-589-016275605890190 TABLET in 1 BOTTLE (62756-589-01) 90 tablet2023-06-26NoNoCurrent
62756-589-0862756058908100 TABLET in 1 BOTTLE (62756-589-08) 100 tablet2019-11-280000-00-00NoNoCurrent
62756-589-18627560589181000 TABLET in 1 BOTTLE (62756-589-18) 1000 tablet2019-11-280000-00-00NoNoCurrent
62756-589-836275605898330 TABLET in 1 BOTTLE (62756-589-83) 30 tablet2019-11-280000-00-00NoNoCurrent
62756-589-8862756058988100 TABLET in 1 BOTTLE (62756-589-88) 100 tablet2019-11-280000-00-00NoNoCurrent