Levothyroxine Sodium

Product NDC
63323-647
11-digit product format
633230647
Labeler code
63323
Product ID
63323-647_1da8e5bc-aeb7-4168-a8c3-e1d9a9d167ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOTHYROXINE SODIUM ANHYDROUS
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA202231
Marketing category
NDA
Marketing start
2011-06-24
Substance
LEVOTHYROXINE SODIUM ANHYDROUS
Active strength
200 ug/5mL
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
054I36CPMNLEVOTHYROXINE SODIUM ANHYDROUS55-03-8LEVOTHYROXINE SODIUM ANHYDROUS

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63323-647-10633230647101 VIAL, SINGLE-DOSE in 1 CARTON (63323-647-10) / 5 mL in 1 VIAL, SINGLE-DOSE2011-06-24NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Levothyroxine SodiumFresenius Kabi USA, LLC2025-04-17HUMAN PRESCRIPTION DRUG LABEL7