FDA.reportPublic FDA data

Levothyroxine sodium

Product NDC
71335-2562
11-digit product format
713352562
Labeler code
71335
Product ID
71335-2562_be577d92-7dbb-48c9-97fe-51ff0cdc44c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207588
Marketing category
ANDA
Marketing start
2022-09-21
Substance
LEVOTHYROXINE SODIUM
Active strength
137 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 SODIUM137 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966270

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
71335-2562-1Levothyroxine sodium30 in 1 BOTTLETABLET301
71335-2562-2Levothyroxine sodium100 in 1 BOTTLETABLET1001
71335-2562-3Levothyroxine sodium90 in 1 BOTTLETABLET901
71335-2562-4Levothyroxine sodium28 in 1 BOTTLETABLET281
71335-2562-5Levothyroxine sodium60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2562LEVOTHYROXINE SODIUM TABLET [BRYANT RANCH PREPACK]1Current NDC, 5 package rows20250130_702016f6-8507-471f-b833-3a582aef5d2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966270levothyroxine sodium 137 MCG Oral TabletPSN702016f6-8507-471f-b833-3a582aef5d2e1
966270levothyroxine sodium 0.137 MG Oral TabletSCD702016f6-8507-471f-b833-3a582aef5d2e1
966270levothyroxine sodium 137 MCG Oral TabletSY702016f6-8507-471f-b833-3a582aef5d2e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2562-17133525620130 TABLET in 1 BOTTLE (71335-2562-1) 30 tablet2025-01-28NoNoHistorical
71335-2562-271335256202100 TABLET in 1 BOTTLE (71335-2562-2) 100 tablet2025-01-28NoNoHistorical
71335-2562-37133525620390 TABLET in 1 BOTTLE (71335-2562-3) 90 tablet2025-01-28NoNoHistorical
71335-2562-47133525620428 TABLET in 1 BOTTLE (71335-2562-4) 28 tablet2025-01-28NoNoHistorical
71335-2562-57133525620560 TABLET in 1 BOTTLE (71335-2562-5) 60 tablet2025-01-28NoNoHistorical