FDA.reportPublic FDA data

Levothyroxine sodium

Product NDC
71335-1881
11-digit product format
713351881
Labeler code
71335
Product ID
71335-1881_abe1dccb-d262-4b86-9f8a-b772622df565
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212399
Marketing category
ANDA
Marketing start
2020-12-10
Substance
LEVOTHYROXINE SODIUM
Active strength
25 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 SODIUM25 ug/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
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
71335-1881-1Levothyroxine sodium30 in 1 BOTTLETABLET30105
71335-1881-2Levothyroxine sodium90 in 1 BOTTLETABLET90105
71335-1881-3Levothyroxine sodium100 in 1 BOTTLETABLET100105
71335-1881-4Levothyroxine sodium60 in 1 BOTTLETABLET60105
71335-1881-5Levothyroxine sodium28 in 1 BOTTLETABLET28105
71335-1881-6Levothyroxine sodium10 in 1 BOTTLETABLET10105
71335-1881-7Levothyroxine sodium1000 in 1 BOTTLETABLET1000105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1881LEVOTHYROXINE SODIUM TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 7 package rows20241225_251e65e0-6925-4984-9df9-d6d7c6d0703c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966220levothyroxine sodium 25 MCG Oral TabletPSN251e65e0-6925-4984-9df9-d6d7c6d0703c105
966220levothyroxine sodium 0.025 MG Oral TabletSCD251e65e0-6925-4984-9df9-d6d7c6d0703c105
966220levothyroxine sodium 25 MCG Oral TabletSY251e65e0-6925-4984-9df9-d6d7c6d0703c105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1881-17133518810130 TABLET in 1 BOTTLE (71335-1881-1) 30 tablet2021-06-010000-00-00NoNoCurrent
71335-1881-27133518810290 TABLET in 1 BOTTLE (71335-1881-2) 90 tablet2021-05-280000-00-00NoNoCurrent
71335-1881-371335188103100 TABLET in 1 BOTTLE (71335-1881-3) 100 tablet2024-12-110000-00-00NoNoCurrent
71335-1881-47133518810460 TABLET in 1 BOTTLE (71335-1881-4) 60 tablet2024-12-110000-00-00NoNoCurrent
71335-1881-57133518810528 TABLET in 1 BOTTLE (71335-1881-5) 28 tablet2024-12-110000-00-00NoNoCurrent
71335-1881-67133518810610 TABLET in 1 BOTTLE (71335-1881-6) 10 tablet2024-12-11NoNoCurrent
71335-1881-7713351881071000 TABLET in 1 BOTTLE (71335-1881-7) 1000 tablet2024-12-11NoNoCurrent