Ibandronate Sodium (Page 7 of 7)

Package/Label Display Panel

NDC 67457-524-33

Ibandronate Sodium Injection

3 mg/3 mL

(1 mg/mL)*

For Intravenous Use Only

Attention Pharmacist: Dispense the enclosed Medication Guide to each patient.

Sterile

Mylan

Rx only

Single-Dose Prefilled Syringe

Carton
(click image for full-size original)
IBANDRONATE SODIUM
ibandronate sodium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-524
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBANDRONATE SODIUM (IBANDRONIC ACID) IBANDRONIC ACID 3 mg in 3 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
ACETIC ACID
SODIUM ACETATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67457-524-33 1 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS
1 3 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (67457-524-33)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202671 09/02/2014
Labeler — Mylan Institutional LLC (790384502)
Registrant — Mylan Laboratories Limited (650548014)
Establishment
Name Address ID/FEI Operations
Mylan Laboratories Limited 676199117 ANALYSIS (67457-524), MANUFACTURE (67457-524), STERILIZE (67457-524), LABEL (67457-524), PACK (67457-524)

Revised: 01/2018 Mylan Institutional LLC

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