FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
71335-1499
11-digit product format
713351499
Labeler code
71335
Product ID
71335-1499_79d57214-910c-4d26-949b-394967e4a536
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA021342
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-08-03
Substance
LEVOTHYROXINE SODIUM
Active strength
125 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 SODIUM125 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966224

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
71335-1499-1Levothyroxine Sodium30 in 1 BOTTLETABLET30101
71335-1499-2Levothyroxine Sodium100 in 1 BOTTLETABLET100101
71335-1499-3Levothyroxine Sodium90 in 1 BOTTLETABLET90101
71335-1499-4Levothyroxine Sodium60 in 1 BOTTLETABLET60101
71335-1499-5Levothyroxine Sodium28 in 1 BOTTLETABLET28101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1499-1EA - Each71335-1499d1fb7422-2989-40fb-ae6b-3fbdb57a78e112023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1499LEVOTHYROXINE SODIUM TABLET [BRYANT RANCH PREPACK]101Current NDC, 5 package rows20240410_489ffba8-983e-478f-8f62-fe08bf3d0e0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966224levothyroxine sodium 125 MCG Oral TabletPSN489ffba8-983e-478f-8f62-fe08bf3d0e0b101
966224levothyroxine sodium 0.125 MG Oral TabletSCD489ffba8-983e-478f-8f62-fe08bf3d0e0b101
966224levothyroxine sodium 125 MCG Oral TabletSY489ffba8-983e-478f-8f62-fe08bf3d0e0b101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-1499-17133514990130 TABLET in 1 BOTTLE (71335-1499-1) 30 tablet2024-04-03NoNoHistorical
71335-1499-271335149902100 TABLET in 1 BOTTLE (71335-1499-2) 100 tablet2024-04-03NoNoHistorical
71335-1499-37133514990390 TABLET in 1 BOTTLE (71335-1499-3) 90 tablet2024-04-03NoNoHistorical
71335-1499-47133514990460 TABLET in 1 BOTTLE (71335-1499-4) 60 tablet2024-04-03NoNoHistorical
71335-1499-57133514990528 TABLET in 1 BOTTLE (71335-1499-5) 28 tablet2024-04-03NoNoHistorical