FDA.reportPublic FDA data

Liothyronine Sodium

Product NDC
42794-020
11-digit product format
427940020
Labeler code
42794
Product ID
42794-020_f1f181e3-ceed-1d17-e053-2995a90af5cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Liothyronine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
SIGMAPHARM LABORATORIES, LLC
Application
ANDA200295
Marketing category
ANDA
Marketing start
2012-12-03
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
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
42794-020-02Liothyronine Sodium100 in 1 BOTTLETABLET1009
42794-020-12Liothyronine Sodium90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42794-020-02EA - Each42794-0202ba1b65c-6542-4b05-b579-d82fc95c70da12013-02-13
42794-020-12EA - Each42794-020ac0467e6-338b-4f81-91b3-a4995d32c84412018-05-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIOTHYRONINE SODIUMACTIVE INGREDIENTGCA9VV7D2NLIOTHYRONINE SODIUM TABLET [SIGMAPHARM LABORATORIES, LLC]3
LIOTHYRONINEACTIVE MOIETY06LU7C9H1VLIOTHYRONINE SODIUM TABLET [SIGMAPHARM LABORATORIES, LLC]3
CALCIUM SULFATE DIHYDRATEINACTIVE INGREDIENT4846Q921YMLIOTHYRONINE SODIUM TABLET [SIGMAPHARM LABORATORIES, LLC]3
GELATININACTIVE INGREDIENT2G86QN327LLIOTHYRONINE SODIUM TABLET [SIGMAPHARM LABORATORIES, LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LIOTHYRONINE SODIUM TABLET [SIGMAPHARM LABORATORIES, LLC]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ALIOTHYRONINE SODIUM TABLET [SIGMAPHARM LABORATORIES, LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLIOTHYRONINE SODIUM TABLET [SIGMAPHARM LABORATORIES, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42794-020LIOTHYRONINE SODIUM TABLET [SIGMAPHARM LABORATORIES, LLC]9Current NDC, Legacy NDC, 2 package rows20230111_38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903703liothyronine sodium 50 MCG Oral TabletPSN20cbf84d-80f2-4b94-ad47-6aaa362fb4d0101
903703liothyronine sodium 0.05 MG Oral TabletSCD20cbf84d-80f2-4b94-ad47-6aaa362fb4d0101
903703liothyronine sodium 50 MCG Oral TabletSY20cbf84d-80f2-4b94-ad47-6aaa362fb4d0101
903697liothyronine sodium 25 MCG Oral TabletPSN38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c9
903456liothyronine sodium 5 MCG Oral TabletPSN38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c9
903703liothyronine sodium 50 MCG Oral TabletPSN38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c9
903456liothyronine sodium 0.005 MG Oral TabletSCD38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c9
903697liothyronine sodium 0.025 MG Oral TabletSCD38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c9
903703liothyronine sodium 0.05 MG Oral TabletSCD38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c9
903697liothyronine sodium 25 MCG Oral TabletSY38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c9
903456liothyronine sodium 5 MCG Oral TabletSY38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c9
903703liothyronine sodium 50 MCG Oral TabletSY38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c9
903697liothyronine sodium 25 MCG Oral TabletPSN26cf6872-f4d4-41dd-8957-a000f13efbb31
903456liothyronine sodium 5 MCG Oral TabletPSN26cf6872-f4d4-41dd-8957-a000f13efbb31
903703liothyronine sodium 50 MCG Oral TabletPSN26cf6872-f4d4-41dd-8957-a000f13efbb31
903456liothyronine sodium 0.005 MG Oral TabletSCD26cf6872-f4d4-41dd-8957-a000f13efbb31
903697liothyronine sodium 0.025 MG Oral TabletSCD26cf6872-f4d4-41dd-8957-a000f13efbb31
903703liothyronine sodium 0.05 MG Oral TabletSCD26cf6872-f4d4-41dd-8957-a000f13efbb31
903697liothyronine sodium 25 MCG Oral TabletSY26cf6872-f4d4-41dd-8957-a000f13efbb31
903456liothyronine sodium 5 MCG Oral TabletSY26cf6872-f4d4-41dd-8957-a000f13efbb31
903703liothyronine sodium 50 MCG Oral TabletSY26cf6872-f4d4-41dd-8957-a000f13efbb31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42794-020-0242794002002100 TABLET in 1 BOTTLE (42794-020-02) 100 tablet2012-12-030000-00-00NoNoCurrent
42794-020-124279400201290 TABLET in 1 BOTTLE (42794-020-12) 90 tablet2018-05-010000-00-00NoNoCurrent