FULVESTRANT injection, solution

FULVESTRANT by

Drug Labeling and Warnings

FULVESTRANT by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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

INGREDIENTS AND APPEARANCE

FULVESTRANT 
fulvestrant injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1626
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FULVESTRANT (UNII: 22X328QOC4) (FULVESTRANT - UNII:22X328QOC4)	FULVESTRANT	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZYL BENZOATE (UNII: N863NB338G)
CASTOR OIL (UNII: D5340Y2I9G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1626-8	2 in 1 CARTON	12/14/2021
1	NDC: 70771-1626-2	5 mL in 1 SYRINGE, GLASS; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215234	12/14/2021

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		677604722	ANALYSIS(70771-1626) , MANUFACTURE(70771-1626)