NDC Code(s) : 23155-170-31
Packager : Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

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:23155-170
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 ANHYDROUS4 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)220 mg in 5 mL
SODIUM CITRATE(UNII: 1Q73Q2JULR)24 mg in 5 mL
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:23155-170-311 in 1 CARTON 31/08/2023
15 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201783 08/31/2023

LABELER - Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901)

REGISTRANT - AVET LIFESCIENCES PRIVATE LIMITED(853181664)

Establishment
Name Address ID/FEI Business Operations
Emcure Pharmaceuticals Limited 675467924 ANALYSIS(23155-170), MANUFACTURE(23155-170), PACK(23155-170), LABEL(23155-170)

PRINCIPAL DISPLAY PANEL

NDC 23155-170-31

Zoledronic Acid Injection

4 mg/5 mL

(0.8 mg/mL)

Rx only

For Intravenous Infusion after Dilution

Not for direct injection.

Dose must be diluted.

Sterile

Single-dose 5 mL vial

zole-label

PRINCIPAL DISPLAY PANEL

NDC 23155-170-31

Zoledronic Acid Injection

4 mg/5 mL

(0.8 mg/mL)

Rx only

For Intravenous Infusion after Dilution

Not for direct injection.

Dose must be diluted.

One single-dose 5 mL vial Sterile

zole-carton