FDA.reportPublic FDA data

Tirosint

Product NDC
71858-0135
11-digit product format
718580135
Labeler code
71858
Product ID
71858-0135_4e04737b-8d88-7c75-e063-6394a90a34c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
SOLUTION
Route
ORAL
Labeler
IBSA Pharma Inc.
Application
NDA206977
Marketing category
NDA
Marketing start
2019-03-01
Substance
LEVOTHYROXINE SODIUM
Active strength
112 ug/mL
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tirosint
Brand name suffix
SOL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM112 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui2056462, 2056466, 2056468, 2056470, 2056472, 2056474, 2056476, 2056478, 2056480, 2056482, 2056484, 2056486, 2056488, 2056490, 2056492, 2056494, 2056496, 2056498, 2056500, 2056502

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
97c252d3-9bb8-4530-bb44-9824dc7cf556Product name620250729
6c43b71c-35e6-4db3-ba24-c6ef42ff7003Product name320240207
890fd4bf-1a80-42b7-be1b-2d0259d5f0c8Product name520240207
c8ad26bf-af73-460b-b74e-1eff16cc4f9fProduct name520240207
01383843-4069-43cf-aa76-dc17a6f9f8c4Product name220230123
978cca7d-a938-4791-8322-da48d90a63efProduct name120230113
65f86ba3-8816-4e12-899b-18290c8de551Product name220210614
f16ab90f-08c2-40be-a543-66d9827cd1f3Product name120210601
6a33ec05-2ae2-45e5-ab82-2d94b3303923Product name120190709
93355a10-1c44-4c92-a11d-7d995e0200d9Product name120190219

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71858-0135-1TirosintSOL2 in 1 CARTONSOLUTION218
71858-0135-2TirosintSOL6 in 1 CARTONSOLUTION618
71858-0135-4TirosintSOL5 in 1 POUCHSOLUTION518
71858-0135-5TirosintSOL6 in 1 CARTONSOLUTION618
71858-0135-6TirosintSOL1 mL in 1 AMPULESOLUTION118

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71858-0135TIROSINT SOL (LEVOTHYROXINE SODIUM) SOLUTION [IBSA PHARMA INC.]16Current NDC, Legacy NDC, 5 package rows20241025_5d378add-f13d-40f2-99dc-0f2340ab44b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2056480levothyroxine sodium 100 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056484levothyroxine sodium 112 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056488levothyroxine sodium 125 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056492levothyroxine sodium 13 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056496levothyroxine sodium 137 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056500levothyroxine sodium 150 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056504levothyroxine sodium 175 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056508levothyroxine sodium 200 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056462levothyroxine sodium 25 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2566613levothyroxine sodium 37.5 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2566617levothyroxine sodium 44 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056468levothyroxine sodium 50 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2566608levothyroxine sodium 62.5 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056472levothyroxine sodium 75 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056476levothyroxine sodium 88 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056482TIROSINT - SOL 100 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056486TIROSINT - SOL 112 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056490TIROSINT - SOL 125 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056494TIROSINT - SOL 13 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056498TIROSINT - SOL 137 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056502TIROSINT - SOL 150 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056506TIROSINT - SOL 175 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056510TIROSINT - SOL 200 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056466TIROSINT - SOL 25 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2566615TIROSINT - SOL 37.5 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2566619TIROSINT - SOL 44 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056470TIROSINT - SOL 50 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2566610TIROSINT - SOL 62.5 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056474TIROSINT - SOL 75 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056478TIROSINT - SOL 88 MCG in 1 mL Oral SolutionPSN5d378add-f13d-40f2-99dc-0f2340ab44b718
2056494levothyroxine sodium 0.013 MG/ML Oral Solution [Tirosint]SBD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056466levothyroxine sodium 0.025 MG/ML Oral Solution [Tirosint]SBD5d378add-f13d-40f2-99dc-0f2340ab44b718
2566615levothyroxine sodium 0.0375 MG/ML Oral Solution [Tirosint]SBD5d378add-f13d-40f2-99dc-0f2340ab44b718
2566619levothyroxine sodium 0.044 MG/ML Oral Solution [Tirosint]SBD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056470levothyroxine sodium 0.05 MG/ML Oral Solution [Tirosint]SBD5d378add-f13d-40f2-99dc-0f2340ab44b718
2566610levothyroxine sodium 0.0625 MG/ML Oral Solution [Tirosint]SBD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056474levothyroxine sodium 0.075 MG/ML Oral Solution [Tirosint]SBD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056478levothyroxine sodium 0.088 MG/ML Oral Solution [Tirosint]SBD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056482levothyroxine sodium 0.1 MG/ML Oral Solution [Tirosint]SBD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056486levothyroxine sodium 0.112 MG/ML Oral Solution [Tirosint]SBD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056490levothyroxine sodium 0.125 MG/ML Oral Solution [Tirosint]SBD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056498levothyroxine sodium 0.137 MG/ML Oral Solution [Tirosint]SBD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056502levothyroxine sodium 0.15 MG/ML Oral Solution [Tirosint]SBD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056506levothyroxine sodium 0.175 MG/ML Oral Solution [Tirosint]SBD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056510levothyroxine sodium 0.2 MG/ML Oral Solution [Tirosint]SBD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056492levothyroxine sodium 0.013 MG/ML Oral SolutionSCD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056462levothyroxine sodium 0.025 MG/ML Oral SolutionSCD5d378add-f13d-40f2-99dc-0f2340ab44b718
2566613levothyroxine sodium 0.0375 MG/ML Oral SolutionSCD5d378add-f13d-40f2-99dc-0f2340ab44b718
2566617levothyroxine sodium 0.044 MG/ML Oral SolutionSCD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056468levothyroxine sodium 0.05 MG/ML Oral SolutionSCD5d378add-f13d-40f2-99dc-0f2340ab44b718
2566608levothyroxine sodium 0.0625 MG/ML Oral SolutionSCD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056472levothyroxine sodium 0.075 MG/ML Oral SolutionSCD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056476levothyroxine sodium 0.088 MG/ML Oral SolutionSCD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056480levothyroxine sodium 0.1 MG/ML Oral SolutionSCD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056484levothyroxine sodium 0.112 MG/ML Oral SolutionSCD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056488levothyroxine sodium 0.125 MG/ML Oral SolutionSCD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056496levothyroxine sodium 0.137 MG/ML Oral SolutionSCD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056500levothyroxine sodium 0.15 MG/ML Oral SolutionSCD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056504levothyroxine sodium 0.175 MG/ML Oral SolutionSCD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056508levothyroxine sodium 0.2 MG/ML Oral SolutionSCD5d378add-f13d-40f2-99dc-0f2340ab44b718
2056480levothyroxine sodium 100 MCG per 1 ML Oral SolutionSY5d378add-f13d-40f2-99dc-0f2340ab44b718
2056484levothyroxine sodium 112 MCG per 1 ML Oral SolutionSY5d378add-f13d-40f2-99dc-0f2340ab44b718
2056488levothyroxine sodium 125 MCG per 1 ML Oral SolutionSY5d378add-f13d-40f2-99dc-0f2340ab44b718
2056492levothyroxine sodium 13 MCG per 1 ML Oral SolutionSY5d378add-f13d-40f2-99dc-0f2340ab44b718
2056496levothyroxine sodium 137 MCG per 1 ML Oral SolutionSY5d378add-f13d-40f2-99dc-0f2340ab44b718
2056504levothyroxine sodium 175 MCG per 1 ML Oral SolutionSY5d378add-f13d-40f2-99dc-0f2340ab44b718
2056508levothyroxine sodium 200 MCG per 1 ML Oral SolutionSY5d378add-f13d-40f2-99dc-0f2340ab44b718
2056462levothyroxine sodium 25 MCG per 1 ML Oral SolutionSY5d378add-f13d-40f2-99dc-0f2340ab44b718
2056468levothyroxine sodium 50 MCG per 1 ML Oral SolutionSY5d378add-f13d-40f2-99dc-0f2340ab44b718
2056472levothyroxine sodium 75 MCG per 1 ML Oral SolutionSY5d378add-f13d-40f2-99dc-0f2340ab44b718
2056476levothyroxine sodium 88 MCG per 1 ML Oral SolutionSY5d378add-f13d-40f2-99dc-0f2340ab44b718
2566615Tirosint 0.0375 MG/ML Oral SolutionSY5d378add-f13d-40f2-99dc-0f2340ab44b718
2566619Tirosint 0.044 MG/ML Oral SolutionSY5d378add-f13d-40f2-99dc-0f2340ab44b718
2566610Tirosint 0.0625 MG/ML Oral SolutionSY5d378add-f13d-40f2-99dc-0f2340ab44b718
2056494Tirosint SOL 0.013 MG per 1 ML Oral SolutionSY5d378add-f13d-40f2-99dc-0f2340ab44b718
2056466Tirosint SOL 0.025 MG per 1 ML Oral SolutionSY5d378add-f13d-40f2-99dc-0f2340ab44b718
2056470Tirosint SOL 0.05 MG per 1 ML Oral SolutionSY5d378add-f13d-40f2-99dc-0f2340ab44b718
2056474Tirosint SOL 0.075 MG per 1 ML Oral SolutionSY5d378add-f13d-40f2-99dc-0f2340ab44b718
2056478Tirosint SOL 0.088 MG per 1 ML Oral SolutionSY5d378add-f13d-40f2-99dc-0f2340ab44b718
2056482Tirosint SOL 0.1 MG per 1 ML Oral SolutionSY5d378add-f13d-40f2-99dc-0f2340ab44b718

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71858-0135-1718580135012 POUCH in 1 CARTON (71858-0135-1) > 5 AMPULE in 1 POUCH (71858-0135-4) > 1 mL in 1 AMPULE2 pouch2019-03-010000-00-00NoNoCurrent
71858-0135-2718580135026 POUCH in 1 CARTON (71858-0135-2) / 5 AMPULE in 1 POUCH (71858-0135-4) / 1 mL in 1 AMPULE (71858-0135-6) 6 pouch2025-07-25YesNoCurrent
71858-0135-4718580135045 in 1 POUCHHistorical
71858-0135-5718580135056 POUCH in 1 CARTON (71858-0135-5) / 5 AMPULE in 1 POUCH (71858-0135-4) / 1 mL in 1 AMPULE (71858-0135-6) 6 pouch2019-03-010000-00-00NoNoCurrent
71858-0135-6718580135061 mL in 1 AMPULE1 mlHistorical