levothyroxine sodium

Product NDC
68788-8648
11-digit product format
687888648
Labeler code
68788
Product ID
68788-8648_bd78156a-c5ec-4686-8b61-d97bf0bafae0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
NDA021116
Marketing category
NDA
Marketing start
2024-05-03
Substance
LEVOTHYROXINE SODIUM
Active strength
25 ug/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
9J765S329GLEVOTHYROXINE SODIUM6106-07-6LEVOTHYROXINE SODIUM

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8648-36878886480330 TABLET in 1 BOTTLE (68788-8648-3) 30 tablet2024-05-03NoNoHistorical
68788-8648-96878886480990 TABLET in 1 BOTTLE (68788-8648-9) 90 tablet2024-05-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
levothyroxine sodiumPreferred Pharmaceuticals Inc.2025-07-14HUMAN PRESCRIPTION DRUG LABEL2