FDA.reportPublic FDA data

Levothyroxine sodium

Product NDC
71335-1828
11-digit product format
713351828
Labeler code
71335
Product ID
71335-1828_9f4d3245-f125-40ff-892f-a5c5ef2cd3ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212399
Marketing category
ANDA
Marketing start
2020-12-03
Substance
LEVOTHYROXINE SODIUM
Active strength
175 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 SODIUM175 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966249

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1828-1Levothyroxine sodium30 in 1 BOTTLETABLET30105
71335-1828-2Levothyroxine sodium90 in 1 BOTTLETABLET90105
71335-1828-3Levothyroxine sodium100 in 1 BOTTLETABLET100105
71335-1828-4Levothyroxine sodium38 in 1 BOTTLETABLET38105
71335-1828-5Levothyroxine sodium28 in 1 BOTTLETABLET28105
71335-1828-6Levothyroxine sodium60 in 1 BOTTLETABLET60105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1828LEVOTHYROXINE SODIUM TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 6 package rows20241225_231fcdf8-c642-4074-8be8-53ee9c918f18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966249levothyroxine sodium 175 MCG Oral TabletPSN231fcdf8-c642-4074-8be8-53ee9c918f18105
966249levothyroxine sodium 0.175 MG Oral TabletSCD231fcdf8-c642-4074-8be8-53ee9c918f18105
966249levothyroxine sodium 175 MCG Oral TabletSY231fcdf8-c642-4074-8be8-53ee9c918f18105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1828-17133518280130 TABLET in 1 BOTTLE (71335-1828-1) 30 tablet2021-07-300000-00-00NoNoCurrent
71335-1828-27133518280290 TABLET in 1 BOTTLE (71335-1828-2) 90 tablet2021-04-050000-00-00NoNoCurrent
71335-1828-371335182803100 TABLET in 1 BOTTLE (71335-1828-3) 100 tablet2024-12-110000-00-00NoNoCurrent
71335-1828-47133518280438 TABLET in 1 BOTTLE (71335-1828-4) 38 tablet2024-12-110000-00-00NoNoCurrent
71335-1828-57133518280528 TABLET in 1 BOTTLE (71335-1828-5) 28 tablet2024-12-110000-00-00NoNoCurrent
71335-1828-67133518280660 TABLET in 1 BOTTLE (71335-1828-6) 60 tablet2024-12-110000-00-00NoNoCurrent