Fulvestrant (Page 7 of 7)

Principal Display Panel – Syringe Label

NDC 0143-9022 -01 Rx only

Fulvestrant Injection

250 mg per 5 mL (50 mg per mL)

For Intramuscular Use ONLY

PROTECT FROM LIGHT

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

602049B02
(click image for full-size original)

Principal Display Panel — Carton with Serialization Placeholder

NDC 0143-9022 -02 Rx only

Fulvestrant Injection

250 mg per 5 mL (50 mg per mL)

For Intramuscular Use ONLY

Contains 2 single-dose prefilled syringes

Fulvestrant carton
(click image for full-size original)

FULVESTRANT fulvestrant injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9022
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:0143-9022-02 2 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS (0143-9022-01)
1 NDC:0143-9022-01 5 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (0143-9022-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214682 02/10/2022
Labeler — Hikma Pharmaceuticals USA Inc. (001230762)
Registrant — Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (547876677)
Establishment
Name Address ID/FEI Operations
Jiangsu Hansoh Pharmaceutical Group Co., Ltd. 421304996 analysis (0143-9022), label (0143-9022), manufacture (0143-9022), pack (0143-9022)

Revised: 06/2022 Hikma Pharmaceuticals USA Inc.

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