FDA.reportPublic FDA data

Tirosint

Product NDC
71858-0010
11-digit product format
718580010
Labeler code
71858
Product ID
71858-0010_4ddc8742-bf50-baa5-e063-6294a90a56eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
IBSA Pharma Inc.
Application
NDA021924
Marketing category
NDA
Marketing start
2018-12-01
Substance
LEVOTHYROXINE SODIUM
Active strength
25 ug/1
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM25 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui905451, 905453, 905455, 905457, 905458, 905460, 905462, 905464, 966404, 966405, 966406, 966407, 966412, 966413, 966415, 966417, 966420, 966423, 966426, 966434

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
71858-0010-1Tirosint1 in 1 CARTONCAPSULE113
71858-0010-1Tirosint10 in 1 BLISTER PACKCAPSULE1013
71858-0010-2Tirosint3 in 1 CARTONCAPSULE313
71858-0010-2Tirosint10 in 1 BLISTER PACKCAPSULE1013
71858-0010-4Tirosint10 in 1 BLISTER PACKCAPSULE1013
71858-0010-4Tirosint3 in 1 CARTONCAPSULE313

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71858-0010-4EA - Each71858-00108f761cf5-7112-4857-b7b7-8b5c293cc31912018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71858-0010TIROSINT (LEVOTHYROXINE SODIUM) CAPSULE [IBSA PHARMA INC.]11Current NDC, Legacy NDC, 6 package rows20241027_7a7ade79-0165-4e31-b84e-667416c00c7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2630746levothyroxine sodium 0.0625 MG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
966404levothyroxine sodium 100 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
905451levothyroxine sodium 112 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
966405levothyroxine sodium 125 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
966412levothyroxine sodium 13 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
905455levothyroxine sodium 137 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
966413levothyroxine sodium 150 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
1923047levothyroxine sodium 175 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
1923050levothyroxine sodium 200 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
966406levothyroxine sodium 25 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
2630738levothyroxine sodium 37.5 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
2630742levothyroxine sodium 44 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
966407levothyroxine sodium 50 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
905458levothyroxine sodium 75 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
905462levothyroxine sodium 88 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
966415Tirosint 100 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
905453Tirosint 112 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
966417Tirosint 125 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
966434Tirosint 13 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
905457Tirosint 137 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
966420Tirosint 150 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
1923049Tirosint 175 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
1923052Tirosint 200 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
966423Tirosint 25 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
2630740Tirosint 37.5 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
2630744Tirosint 44 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
966426Tirosint 50 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
2630748Tirosint 62.5 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
905460Tirosint 75 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
905464Tirosint 88 MCG Oral CapsulePSN7a7ade79-0165-4e31-b84e-667416c00c7e13
966434levothyroxine sodium 0.013 MG Oral Capsule [Tirosint]SBD7a7ade79-0165-4e31-b84e-667416c00c7e13
966423levothyroxine sodium 0.025 MG Oral Capsule [Tirosint]SBD7a7ade79-0165-4e31-b84e-667416c00c7e13
2630740levothyroxine sodium 0.0375 MG Oral Capsule [Tirosint]SBD7a7ade79-0165-4e31-b84e-667416c00c7e13
2630744levothyroxine sodium 0.044 MG Oral Capsule [Tirosint]SBD7a7ade79-0165-4e31-b84e-667416c00c7e13
966426levothyroxine sodium 0.05 MG Oral Capsule [Tirosint]SBD7a7ade79-0165-4e31-b84e-667416c00c7e13
2630748levothyroxine sodium 0.0625 MG Oral Capsule [Tirosint]SBD7a7ade79-0165-4e31-b84e-667416c00c7e13
905460levothyroxine sodium 0.075 MG Oral Capsule [Tirosint]SBD7a7ade79-0165-4e31-b84e-667416c00c7e13
905464levothyroxine sodium 0.088 MG Oral Capsule [Tirosint]SBD7a7ade79-0165-4e31-b84e-667416c00c7e13
966415levothyroxine sodium 0.1 MG Oral Capsule [Tirosint]SBD7a7ade79-0165-4e31-b84e-667416c00c7e13
905453levothyroxine sodium 0.112 MG Oral Capsule [Tirosint]SBD7a7ade79-0165-4e31-b84e-667416c00c7e13
966417levothyroxine sodium 0.125 MG Oral Capsule [Tirosint]SBD7a7ade79-0165-4e31-b84e-667416c00c7e13
905457levothyroxine sodium 0.137 MG Oral Capsule [Tirosint]SBD7a7ade79-0165-4e31-b84e-667416c00c7e13
966420levothyroxine sodium 0.15 MG Oral Capsule [Tirosint]SBD7a7ade79-0165-4e31-b84e-667416c00c7e13
1923049levothyroxine sodium 0.175 MG Oral Capsule [Tirosint]SBD7a7ade79-0165-4e31-b84e-667416c00c7e13
1923052levothyroxine sodium 0.2 MG Oral Capsule [Tirosint]SBD7a7ade79-0165-4e31-b84e-667416c00c7e13
966412levothyroxine sodium 0.013 MG Oral CapsuleSCD7a7ade79-0165-4e31-b84e-667416c00c7e13
966406levothyroxine sodium 0.025 MG Oral CapsuleSCD7a7ade79-0165-4e31-b84e-667416c00c7e13
2630738levothyroxine sodium 0.0375 MG Oral CapsuleSCD7a7ade79-0165-4e31-b84e-667416c00c7e13
2630742levothyroxine sodium 0.044 MG Oral CapsuleSCD7a7ade79-0165-4e31-b84e-667416c00c7e13
966407levothyroxine sodium 0.05 MG Oral CapsuleSCD7a7ade79-0165-4e31-b84e-667416c00c7e13
2630746levothyroxine sodium 0.0625 MG Oral CapsuleSCD7a7ade79-0165-4e31-b84e-667416c00c7e13
905458levothyroxine sodium 0.075 MG Oral CapsuleSCD7a7ade79-0165-4e31-b84e-667416c00c7e13
905462levothyroxine sodium 0.088 MG Oral CapsuleSCD7a7ade79-0165-4e31-b84e-667416c00c7e13
966404levothyroxine sodium 0.1 MG Oral CapsuleSCD7a7ade79-0165-4e31-b84e-667416c00c7e13
905451levothyroxine sodium 0.112 MG Oral CapsuleSCD7a7ade79-0165-4e31-b84e-667416c00c7e13
966405levothyroxine sodium 0.125 MG Oral CapsuleSCD7a7ade79-0165-4e31-b84e-667416c00c7e13
905455levothyroxine sodium 0.137 MG Oral CapsuleSCD7a7ade79-0165-4e31-b84e-667416c00c7e13
966413levothyroxine sodium 0.15 MG Oral CapsuleSCD7a7ade79-0165-4e31-b84e-667416c00c7e13
1923047levothyroxine sodium 0.175 MG Oral CapsuleSCD7a7ade79-0165-4e31-b84e-667416c00c7e13
1923050levothyroxine sodium 0.2 MG Oral CapsuleSCD7a7ade79-0165-4e31-b84e-667416c00c7e13
966404levothyroxine sodium 100 MCG Oral CapsuleSY7a7ade79-0165-4e31-b84e-667416c00c7e13
905451levothyroxine sodium 112 MCG Oral CapsuleSY7a7ade79-0165-4e31-b84e-667416c00c7e13
966405levothyroxine sodium 125 MCG Oral CapsuleSY7a7ade79-0165-4e31-b84e-667416c00c7e13
966412levothyroxine sodium 13 MCG Oral CapsuleSY7a7ade79-0165-4e31-b84e-667416c00c7e13
905455levothyroxine sodium 137 MCG Oral CapsuleSY7a7ade79-0165-4e31-b84e-667416c00c7e13
966413levothyroxine sodium 150 MCG Oral CapsuleSY7a7ade79-0165-4e31-b84e-667416c00c7e13
1923047levothyroxine sodium 175 MCG Oral CapsuleSY7a7ade79-0165-4e31-b84e-667416c00c7e13
1923050levothyroxine sodium 200 MCG Oral CapsuleSY7a7ade79-0165-4e31-b84e-667416c00c7e13
966406levothyroxine sodium 25 MCG Oral CapsuleSY7a7ade79-0165-4e31-b84e-667416c00c7e13
2630738levothyroxine sodium 37.5 MCG Oral CapsuleSY7a7ade79-0165-4e31-b84e-667416c00c7e13
2630742levothyroxine sodium 44 MCG Oral CapsuleSY7a7ade79-0165-4e31-b84e-667416c00c7e13
966407levothyroxine sodium 50 MCG Oral CapsuleSY7a7ade79-0165-4e31-b84e-667416c00c7e13
2630746levothyroxine sodium 62.5 MCG Oral CapsuleSY7a7ade79-0165-4e31-b84e-667416c00c7e13
905458levothyroxine sodium 75 MCG Oral CapsuleSY7a7ade79-0165-4e31-b84e-667416c00c7e13
905462levothyroxine sodium 88 MCG Oral CapsuleSY7a7ade79-0165-4e31-b84e-667416c00c7e13
966434Tirosint 0.013 MG Oral CapsuleSY7a7ade79-0165-4e31-b84e-667416c00c7e13
966423Tirosint 0.025 MG Oral CapsuleSY7a7ade79-0165-4e31-b84e-667416c00c7e13
2630740Tirosint 0.0375 MG Oral CapsuleSY7a7ade79-0165-4e31-b84e-667416c00c7e13
2630744Tirosint 0.044 MG Oral CapsuleSY7a7ade79-0165-4e31-b84e-667416c00c7e13
966426Tirosint 0.05 MG Oral CapsuleSY7a7ade79-0165-4e31-b84e-667416c00c7e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71858-0010-1718580010011 BLISTER PACK in 1 CARTON (71858-0010-1) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2018-12-012026-07-22YesNoCurrent
71858-0010-2718580010023 BLISTER PACK in 1 CARTON (71858-0010-2) / 10 CAPSULE in 1 BLISTER PACK3 blister pack2025-08-24YesNoCurrent
71858-0010-4718580010043 BLISTER PACK in 1 CARTON (71858-0010-4) / 10 CAPSULE in 1 BLISTER PACK3 blister pack2018-12-010000-00-00NoNoCurrent