levothyroxine sodium

Product NDC
68788-7689
11-digit product format
687887689
Labeler code
68788
Product ID
68788-7689_19da1322-c3d0-4527-acce-95766b7e2dc7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
NDA021116
Marketing category
NDA
Marketing start
2020-04-01
Substance
LEVOTHYROXINE SODIUM
Active strength
125 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 SODIUM125 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966224

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7689-36878876890330 TABLET in 1 BOTTLE (68788-7689-3) 30 tablet2020-04-010000-00-00NoNoCurrent
68788-7689-96878876890990 TABLET in 1 BOTTLE (68788-7689-9) 90 tablet2020-04-010000-00-00NoNoCurrent