FULVESTRANT - fulvestrant injection, solution 
Zydus Lifesciences Limited

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Fulvestrant Injection

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1626-2

 

Fulvestrant Injection

 

250 mg/5 mL (50 mg/mL)

 

For Intramuscular Use Only

 

Both single-dose prefilled syringes must be administered to receive the 500 mg dose.

 

PROTECT FROM LIGHT

 

Rx only

 

Made in India

pfs mfg label

NDC 70771-1626-8

 

Fulvestrant Injection

 

250 mg/5 mL (50 mg/mL)

 

For Intramuscular Use Only

 

This carton contains a total of 500 mg fulvestrant in TWO single-dose prefilled syringes each containing 250 mg/5 mL, and two Safety Glide™ shielding intramuscular injection needles.

 

Discard each syringe after use.

 

Both single-dose prefilled syringes must be administered to receive the 500 mg dose.

 

STORAGE: REFRIGERATE 2° to 8°C (36° to 46°F). TO PROTECT FROM LIGHT, STORE IN THE ORIGINAL CARTON UNTIL TIME OF USE.

 

Contains 2 Single-Dose Prefilled Syringes

 

Rx only

carton mfg label
FULVESTRANT 
fulvestrant injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1626
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FULVESTRANT (UNII: 22X328QOC4) (FULVESTRANT - UNII:22X328QOC4) FULVESTRANT50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BENZYL BENZOATE (UNII: N863NB338G)  
CASTOR OIL (UNII: D5340Y2I9G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1626-82 in 1 CARTON12/14/2021
1NDC:70771-1626-25 mL in 1 SYRINGE, GLASS; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21523412/14/2021
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited677604722ANALYSIS(70771-1626) , MANUFACTURE(70771-1626)

Revised: 8/2022
Document Id: 6908877d-222b-43e6-a7e9-f264fae84be4
Set id: 151b948a-3106-497a-b1c7-479307faeb89
Version: 2
Effective Time: 20220826
 
Zydus Lifesciences Limited