Levothyroxine Sodium

Product NDC
68788-8793
11-digit product format
687888793
Labeler code
68788
Product ID
68788-8793_a0ffe111-3574-4481-a732-b68a7d58ef71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA209713
Marketing category
ANDA
Marketing start
2024-12-17
Substance
LEVOTHYROXINE SODIUM
Active strength
.175 mg/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 SODIUM.175 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966249

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8793-36878887930330 TABLET in 1 BOTTLE (68788-8793-3) 30 tablet2024-12-17NoNoHistorical
68788-8793-96878887930990 TABLET in 1 BOTTLE (68788-8793-9) 90 tablet2024-12-17NoNoHistorical