NDC Code(s) : 67457-225-00, 67457-225-10, 67457-222-00, 67457-222-20
Packager : Mylan Institutional LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Vancomycin HydrochlorideVancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-225
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Vancomycin Hydrochloride(UNII: 71WO621TJD)
(Vancomycin - UNII:6Q205EH1VU) 		Vancomycin500 mg in 10 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67457-225-1010 in 1 CARTON
1NDC:67457-225-0010 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065401 01/10/2012
Vancomycin HydrochlorideVancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-222
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Vancomycin Hydrochloride(UNII: 71WO621TJD)
(Vancomycin - UNII:6Q205EH1VU) 		Vancomycin1 g in 20 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67457-222-2010 in 1 CARTON
1NDC:67457-222-0020 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065401 06/30/2008

PRINCIPAL DISPLAY PANEL

NDC 67457-225-10


Vancomycin HCl
for Injection, USP
500 mg

Equivalent to
500 mg vancomycin

For Intravenous Use Only

AFTER RECONSTITUTION MUST BE FURTHER DILUTED
BEFORE USE. SEE ACCOMPANYING PRESCRIBING
INFORMATION.

Rx only     10 x 500 mg Sterile Vials

IMPORTANT: READ INSERT FOR
PRECAUTIONS AND DIRECTIONS BEFORE
USE.

Preservative Free. Sterile. Lyophilized.

Each vial contains: Vancomycin hydrochloride
equivalent to 500 mg vancomycin.

Usual Adult Dosage: 2 g daily in divided
doses. See accompanying prescribing
information.

Dilute contents of the vial with 10 mL Sterile
Water for injection.

Prior to reconstitution: Store dry powder at
20° to 25°C (68° to 77°F). [See USP Controlled
Room Temperature.]

After reconstitution: This vial may be stored in
a refrigerator for 96 hours without significant
loss of potency.

Manufactured for:
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.

Manufactured by MN Pharmaceuticals

Made in Turkey     MI:225:10C:R2

Vancomycin HCl for Injection, USP 500 mg Carton Label

PRINCIPAL DISPLAY PANEL

NDC 67457-222-20


Vancomycin HCl
for Injection, USP
1 g

Equivalent to
1 g vancomycin

For Intravenous Use Only

AFTER RECONSTITUTION MUST BE FURTHER DILUTED
BEFORE USE. SEE ACCOMPANYING PRESCRIBING
INFORMATION.

Rx only     10 x 1 g Sterile Vials

IMPORTANT: READ INSERT FOR
PRECAUTIONS AND DIRECTIONS BEFORE
USE.

Preservative Free. Sterile. Lyophilized.

Each vial contains: Vancomycin hydrochloride
equivalent to 1 g vancomycin.

Usual Adult Dosage: 2 g daily in divided doses. See
accompanying prescribing information.

Dilute contents of the vial with 20 mL Sterile
Water for injection.

Prior to reconstitution: Store dry powder at 20° to
25°C (68° to 77°F). [See USP Controlled Room
Temperature.]

After reconstitution: This vial may be stored in a
refrigerator for 96 hours without significant loss of
potency.

Manufactured for:
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.

Manufactured by MN Pharmaceuticals

Made in Turkey     MI:222:10C:R2

Vancomycin HCl for Injection, USP 1 g Carton Label