Levothyroxine sodium

Product NDC
71335-2538
11-digit product format
713352538
Labeler code
71335
Product ID
71335-2538_f7c72bdd-38c1-4531-87c4-55761f0d6080
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
88 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 SODIUM88 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966253

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2538-17133525380130 TABLET in 1 BOTTLE (71335-2538-1) 30 tablet2024-12-10NoNoHistorical
71335-2538-27133525380290 TABLET in 1 BOTTLE (71335-2538-2) 90 tablet2024-12-10NoNoHistorical
71335-2538-37133525380328 TABLET in 1 BOTTLE (71335-2538-3) 28 tablet2024-12-10NoNoHistorical
71335-2538-471335253804100 TABLET in 1 BOTTLE (71335-2538-4) 100 tablet2024-12-10NoNoHistorical
71335-2538-57133525380560 TABLET in 1 BOTTLE (71335-2538-5) 60 tablet2024-12-10NoNoHistorical