FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
71335-2549
11-digit product format
713352549
Labeler code
71335
Product ID
71335-2549_e56bfe7c-ed11-44ac-a1fd-9299778233f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209713
Marketing category
ANDA
Marketing start
2019-03-20
Substance
LEVOTHYROXINE SODIUM
Active strength
.025 mg/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 SODIUM.025 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966220

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
71335-2549-1Levothyroxine Sodium30 in 1 BOTTLETABLET301
71335-2549-2Levothyroxine Sodium90 in 1 BOTTLETABLET901
71335-2549-3Levothyroxine Sodium100 in 1 BOTTLETABLET1001
71335-2549-4Levothyroxine Sodium60 in 1 BOTTLETABLET601
71335-2549-5Levothyroxine Sodium28 in 1 BOTTLETABLET281
71335-2549-6Levothyroxine Sodium10 in 1 BOTTLETABLET101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2549LEVOTHYROXINE SODIUM TABLET [BRYANT RANCH PREPACK]1Current NDC, 6 package rows20250123_ddec2148-f97e-4a79-9943-4bef2386a7f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966220levothyroxine sodium 25 MCG Oral TabletPSNddec2148-f97e-4a79-9943-4bef2386a7f21
966220levothyroxine sodium 0.025 MG Oral TabletSCDddec2148-f97e-4a79-9943-4bef2386a7f21
966220levothyroxine sodium 25 MCG Oral TabletSYddec2148-f97e-4a79-9943-4bef2386a7f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2549-17133525490130 TABLET in 1 BOTTLE (71335-2549-1) 30 tablet2025-01-21NoNoHistorical
71335-2549-27133525490290 TABLET in 1 BOTTLE (71335-2549-2) 90 tablet2025-01-21NoNoHistorical
71335-2549-371335254903100 TABLET in 1 BOTTLE (71335-2549-3) 100 tablet2025-01-21NoNoHistorical
71335-2549-47133525490460 TABLET in 1 BOTTLE (71335-2549-4) 60 tablet2025-01-21NoNoHistorical
71335-2549-57133525490528 TABLET in 1 BOTTLE (71335-2549-5) 28 tablet2025-01-21NoNoHistorical
71335-2549-67133525490610 TABLET in 1 BOTTLE (71335-2549-6) 10 tablet2025-01-21NoNoHistorical