LEVOTHYROXINE SODIUM

Product NDC
68788-8807
11-digit product format
687888807
Labeler code
68788
Product ID
68788-8807_7ade3f9e-e3d2-401b-a6b7-aa4c9d1c9861
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOTHYROXINE SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA211417
Marketing category
ANDA
Marketing start
2025-01-20
Substance
LEVOTHYROXINE SODIUM
Active strength
100 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
68788-8807-36878888070330 TABLET in 1 BOTTLE (68788-8807-3) 30 tablet2025-01-20NoNoHistorical
68788-8807-96878888070990 TABLET in 1 BOTTLE (68788-8807-9) 90 tablet2025-01-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.2025-01-20HUMAN PRESCRIPTION DRUG LABEL1