LEVOTHYROXINE SODIUM

Product NDC
70710-1835
11-digit product format
707101835
Labeler code
70710
Product ID
70710-1835_2ef84f1a-cf9a-4e93-8b2b-08bf75befd9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA217066
Marketing category
ANDA
Marketing start
2024-11-01
Substance
LEVOTHYROXINE SODIUM ANHYDROUS
Active strength
500 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
9J765S329GLEVOTHYROXINE SODIUM6106-07-6levothyroxine sodium

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70710-1835-1707101835011 VIAL, SINGLE-DOSE in 1 CARTON (70710-1835-1) / 5 mL in 1 VIAL, SINGLE-DOSE2024-11-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LEVOTHYROXINE SODIUMZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2025-09-16HUMAN PRESCRIPTION DRUG LABEL4