LEVOTHYROXINE SODIUM

Product NDC
70518-4438
11-digit product format
705184438
Labeler code
70518
Product ID
70518-4438_3c406694-a72a-a93f-e063-6294a90a034f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOTHYROXINE SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA211417
Marketing category
ANDA
Marketing start
2025-08-13
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

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4438-07051844380090 TABLET in 1 BOTTLE (70518-4438-0) 90 tablet2025-08-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LEVOTHYROXINE SODIUMREMEDYREPACK INC.2025-08-13HUMAN PRESCRIPTION DRUG LABEL1