LEVOTHYROXINE SODIUM

Product NDC
68788-4005
11-digit product format
687884005
Labeler code
68788
Product ID
68788-4005_609352a9-740f-4874-997b-60b58d0c2b8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOTHYROXINE SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA211417
Marketing category
ANDA
Marketing start
2025-08-01
Substance
LEVOTHYROXINE SODIUM
Active strength
50 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 SODIUM50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-4005-36878840050330 TABLET in 1 BOTTLE (68788-4005-3) 30 tablet2025-08-01NoNoHistorical
68788-4005-96878840050990 TABLET in 1 BOTTLE (68788-4005-9) 90 tablet2025-08-01NoNoHistorical