FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
71335-9762
11-digit product format
713359762
Labeler code
71335
Product ID
71335-9762_27102784-f56d-4edd-b68b-f8cc89f5b993
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
50 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 SODIUM50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966221

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
71335-9762-1Levothyroxine Sodium30 in 1 BOTTLETABLET30104
71335-9762-2Levothyroxine Sodium90 in 1 BOTTLETABLET90104
71335-9762-3Levothyroxine Sodium100 in 1 BOTTLETABLET100104
71335-9762-4Levothyroxine Sodium7 in 1 BOTTLETABLET7104
71335-9762-5Levothyroxine Sodium14 in 1 BOTTLETABLET14104
71335-9762-6Levothyroxine Sodium60 in 1 BOTTLETABLET60104
71335-9762-7Levothyroxine Sodium21 in 1 BOTTLETABLET21104
71335-9762-8Levothyroxine Sodium42 in 1 BOTTLETABLET42104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9762-1EA - Each71335-9762e735fff0-e077-4406-9d6a-21a8a4f4bca812023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9762LEVOTHYROXINE SODIUM TABLET [BRYANT RANCH PREPACK]104Current NDC, 8 package rows20240605_56c633a9-3f64-46bd-b93f-afbff92b5559.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966221levothyroxine sodium 50 MCG Oral TabletPSN56c633a9-3f64-46bd-b93f-afbff92b5559104
966221levothyroxine sodium 0.05 MG Oral TabletSCD56c633a9-3f64-46bd-b93f-afbff92b5559104
966221levothyroxine sodium 50 MCG Oral TabletSY56c633a9-3f64-46bd-b93f-afbff92b5559104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9762-17133597620130 TABLET in 1 BOTTLE (71335-9762-1) 30 tablet2024-03-04NoNoHistorical
71335-9762-27133597620290 TABLET in 1 BOTTLE (71335-9762-2) 90 tablet2024-04-05NoNoHistorical
71335-9762-371335976203100 TABLET in 1 BOTTLE (71335-9762-3) 100 tablet2024-04-05NoNoHistorical
71335-9762-4713359762047 TABLET in 1 BOTTLE (71335-9762-4) 7 tablet2024-04-05NoNoHistorical
71335-9762-57133597620514 TABLET in 1 BOTTLE (71335-9762-5) 14 tablet2024-04-05NoNoHistorical
71335-9762-67133597620660 TABLET in 1 BOTTLE (71335-9762-6) 60 tablet2024-04-05NoNoHistorical
71335-9762-77133597620721 TABLET in 1 BOTTLE (71335-9762-7) 21 tablet2024-04-05NoNoHistorical
71335-9762-87133597620842 TABLET in 1 BOTTLE (71335-9762-8) 42 tablet2024-04-05NoNoHistorical