LEVOTHYROXINE SODIUM- levothyroxine sodium injection, powder, lyophilized, for solution 
Zydus Lifesciences Limited

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Levothyroxine Sodium for Injection

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1818-1

Levothyroxine Sodium for Injection

100 mcg per vial

For Intravenous Use

Discard any unused portion

Single-Dose Vial

Rx only

100 mcg carton label

NDC 70771-1819-1

Levothyroxine Sodium for Injection

200 mcg per vial

For Intravenous Use

Discard any unused portion

Single-Dose Vial

Rx only

200 mcg carton label

NDC 70771-1820-1

Levothyroxine Sodium for Injection

500 mcg per vial

For Intravenous Use

Discard any unused portion

Single-Dose Vial

Rx only

500 mcg label
LEVOTHYROXINE SODIUM 
levothyroxine sodium injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1818
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOTHYROXINE SODIUM ANHYDROUS (UNII: 054I36CPMN) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS100 ug  in 5 mL
Inactive Ingredients
Ingredient NameStrength
MANNITOL (UNII: 3OWL53L36A)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
ColorWHITE (white to off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1818-11 in 1 CARTON11/01/2024
15 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21706611/01/2024
LEVOTHYROXINE SODIUM 
levothyroxine sodium injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1819
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOTHYROXINE SODIUM ANHYDROUS (UNII: 054I36CPMN) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS500 ug  in 5 mL
Inactive Ingredients
Ingredient NameStrength
MANNITOL (UNII: 3OWL53L36A)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
ColorWHITE (white to off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1819-11 in 1 CARTON11/01/2024
15 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21706611/01/2024
LEVOTHYROXINE SODIUM 
levothyroxine sodium injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1820
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOTHYROXINE SODIUM ANHYDROUS (UNII: 054I36CPMN) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS200 ug  in 5 mL
Inactive Ingredients
Ingredient NameStrength
MANNITOL (UNII: 3OWL53L36A)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
ColorWHITE (white to off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1820-11 in 1 CARTON11/01/2024
15 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21706611/01/2024
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited873671928MANUFACTURE(70771-1818, 70771-1819, 70771-1820) , ANALYSIS(70771-1818, 70771-1819, 70771-1820)

Revised: 10/2024
Document Id: 713d5225-2e76-463e-bcd8-9b19f63491da
Set id: f8a8dab3-3bd5-4238-b040-c42aa506ff73
Version: 2
Effective Time: 20241024
 
Zydus Lifesciences Limited