NDC Code(s) : 25021-801-67
Packager : Sagent Pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Zoledronic AcidZoledronic Acid INJECTION, SOLUTION, CONCENTRATE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25021-801
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zoledronic Acid(UNII: 6XC1PAD3KF)
(Zoledronic Acid Anhydrous - UNII:70HZ18PH24) 		Zoledronic Acid Anhydrous0.8 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Mannitol(UNII: 3OWL53L36A)
sodium citrate(UNII: 1Q73Q2JULR)
water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:25021-801-671 in 1 CARTON 09/01/2015
15 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091493 09/01/2015

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label

NDC 25021-801-67

Zoledronic Acid Injection

4 mg per 5 mL

(0.8 mg per mL)

Rx only

Sterile Concentrate

for Intravenous Infusion

5 mL Single-Use Vial

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label