FDA.reportPublic FDA data

levothyroxine sodium

Product NDC
68071-5235
11-digit product format
680715235
Labeler code
68071
Product ID
68071-5235_1b593159-b796-10ad-e063-6294a90abd25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
NuCar Pharmaceuticals,Inc.
Application
NDA021116
Marketing category
NDA
Marketing start
2019-05-07
Substance
LEVOTHYROXINE SODIUM
Active strength
100 ug/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
levothyroxine sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM100 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui892246

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5235-92022-02-07C16284748780-1d6a99b39-bc6a-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002
68071-5235-92022-01-28C16284748780-1d6a99b39-bc6a-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5235-9levothyroxine sodium90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5235LEVOTHYROXINE SODIUM TABLET [NUCAR PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240622_a2194c58-b755-e6b5-e053-2a95a90a36d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892246levothyroxine sodium 100 MCG Oral TabletPSNa2194c58-b755-e6b5-e053-2a95a90a36d43
892246levothyroxine sodium 0.1 MG Oral TabletSCDa2194c58-b755-e6b5-e053-2a95a90a36d43
892246levothyroxine sodium 100 MCG Oral TabletSYa2194c58-b755-e6b5-e053-2a95a90a36d43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5235-96807152350990 TABLET in 1 BOTTLE (68071-5235-9) 90 tablet2020-03-300000-00-00NoNoCurrent