NDC Code(s) : 24208-002-02
Packager : Bausch & Lomb Incorporated

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

VITRASEhyaluronidase, ovine INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24208-002
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYALURONIDASE, OVINE(UNII: 64R4OHP8T0)
(HYALURONIDASE, OVINE - UNII:64R4OHP8T0) 		HYALURONIDASE, OVINE200 [USP'U] in 1 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM PHOSPHATE, MONOBASIC(UNII: 4J9FJ0HL51)0.23 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)9.0 mg in 1 mL
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
DIBASIC POTASSIUM PHOSPHATE(UNII: CI71S98N1Z)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24208-002-022 in 1 CARTON 02/01/2005
11.2 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA021640 02/01/2005

LABELER - Bausch & Lomb Incorporated(196603781)

Establishment
Name Address ID/FEI Business Operations
Alliance Medical Products, Inc. (dba Siegfried Irvine) 102688657 ANALYSIS(24208-002), LABEL(24208-002), MANUFACTURE(24208-002), PACK(24208-002)

PRINCIPAL DISPLAY PANEL

NDC 24208-002-02

Vitrase®
(hyaluronidase injection)
Ovine
200 USP UNITS/mL
Sterile
NOT FOR IV USE
Rx only

2 Single-Use Vials (Nonpreserved)
Contains 1.2 mL per vial

BAUSCH+LOMB

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