Fulvestrant (Page 7 of 7)

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NDC 68842-301-01 Rx only

Fulvestrant Injection

250 mg/5 mL (50 mg/mL)

For Intramuscular Use Only

PROTECT FROM LIGHT.

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

Date/Site: _____________________

Administered by: ___________________

Label
(click image for full-size original)
FULVESTRANT fulvestrant injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68842-301
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FULVESTRANT (FULVESTRANT) FULVESTRANT 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
BENZYL ALCOHOL
BENZYL BENZOATE
CASTOR OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68842-301-12 2 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS (68842-301-01)
1 NDC:68842-301-01 5 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (68842-301-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205935 05/29/2019
Labeler — EBEWE Pharma Ges.m.b.H. Nfg.KG (300529422)

Revised: 11/2019 EBEWE Pharma Ges.m.b.H. Nfg.KG

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