LEVOTHYROXINE SODIUM

Product NDC
70518-4435
11-digit product format
705184435
Labeler code
70518
Product ID
70518-4435_3c30db9f-cbe5-97e5-e063-6294a90a8c4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOTHYROXINE SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA211417
Marketing category
ANDA
Marketing start
2025-08-12
Substance
LEVOTHYROXINE SODIUM
Active strength
75 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
70518-4435-07051844350090 TABLET in 1 BOTTLE (70518-4435-0) 90 tablet2025-08-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LEVOTHYROXINE SODIUMREMEDYREPACK INC.2025-08-12HUMAN PRESCRIPTION DRUG LABEL1