FDA.reportPublic FDA data

Liothyronine sodium

Product NDC
70377-116
11-digit product format
703770116
Labeler code
70377
Product ID
70377-116_c2af2408-91ba-b0c3-349f-20ca285e0fc9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Liothyronine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Biocon Pharma Inc.
Application
ANDA218070
Marketing category
ANDA
Marketing start
2024-02-12
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
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
70377-116-11Liothyronine sodium90 in 1 BOTTLETABLET904
70377-116-12Liothyronine sodium100 in 1 BOTTLETABLET1004
70377-116-13Liothyronine sodium1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70377-116-12EA - Each70377-11660865ad7-edeb-4e4f-a4e3-7014e8fe4bf412024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70377-116LIOTHYRONINE SODIUM TABLET [BIOCON PHARMA INC.]4Current NDC, 3 package rows20240405_21002702-422b-1402-73b8-670314d8e579.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903697liothyronine sodium 25 MCG Oral TabletPSN21002702-422b-1402-73b8-670314d8e5794
903456liothyronine sodium 5 MCG Oral TabletPSN21002702-422b-1402-73b8-670314d8e5794
903703liothyronine sodium 50 MCG Oral TabletPSN21002702-422b-1402-73b8-670314d8e5794
903456liothyronine sodium 0.005 MG Oral TabletSCD21002702-422b-1402-73b8-670314d8e5794
903697liothyronine sodium 0.025 MG Oral TabletSCD21002702-422b-1402-73b8-670314d8e5794
903703liothyronine sodium 0.05 MG Oral TabletSCD21002702-422b-1402-73b8-670314d8e5794
903697liothyronine sodium 25 MCG Oral TabletSY21002702-422b-1402-73b8-670314d8e5794
903456liothyronine sodium 5 MCG Oral TabletSY21002702-422b-1402-73b8-670314d8e5794
903703liothyronine sodium 50 MCG Oral TabletSY21002702-422b-1402-73b8-670314d8e5794

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70377-116-117037701161190 TABLET in 1 BOTTLE (70377-116-11) 90 tablet2024-02-12NoNoCurrent
70377-116-1270377011612100 TABLET in 1 BOTTLE (70377-116-12) 100 tablet2024-02-12NoNoCurrent
70377-116-13703770116131000 TABLET in 1 BOTTLE (70377-116-13) 1000 tablet2024-02-12NoNoCurrent