FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
71335-1734
11-digit product format
713351734
Labeler code
71335
Product ID
71335-1734_4ece19ad-af1a-445f-8f91-10a733a24c32
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
88 ug/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levothyroxine Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM88 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966253

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
71335-1734-1Levothyroxine Sodium30 in 1 BOTTLETABLET30103
71335-1734-2Levothyroxine Sodium90 in 1 BOTTLETABLET90103
71335-1734-3Levothyroxine Sodium28 in 1 BOTTLETABLET28103
71335-1734-4Levothyroxine Sodium100 in 1 BOTTLETABLET100103
71335-1734-5Levothyroxine Sodium60 in 1 BOTTLETABLET60103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1734LEVOTHYROXINE SODIUM TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20240410_64a663ac-ac02-4325-8f21-ee212e546121.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966253levothyroxine sodium 88 MCG Oral TabletPSN64a663ac-ac02-4325-8f21-ee212e546121103
966253levothyroxine sodium 0.088 MG Oral TabletSCD64a663ac-ac02-4325-8f21-ee212e546121103
966253levothyroxine sodium 88 MCG Oral TabletSY64a663ac-ac02-4325-8f21-ee212e546121103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1734-17133517340130 TABLET in 1 BOTTLE (71335-1734-1) 30 tablet2020-11-160000-00-00NoNoCurrent
71335-1734-27133517340290 TABLET in 1 BOTTLE (71335-1734-2) 90 tablet2020-11-170000-00-00NoNoCurrent
71335-1734-37133517340328 TABLET in 1 BOTTLE (71335-1734-3) 28 tablet2024-04-040000-00-00NoNoCurrent
71335-1734-471335173404100 TABLET in 1 BOTTLE (71335-1734-4) 100 tablet2022-03-140000-00-00NoNoCurrent
71335-1734-57133517340560 TABLET in 1 BOTTLE (71335-1734-5) 60 tablet2024-04-040000-00-00NoNoCurrent