NDC Code(s) : 63323-494-41, 63323-494-16
Packager : Fresenius Kabi USA, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Valproate Sodium VALPROATE SODIUM INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-494
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALPROATE SODIUM (UNII: 5VOM6GYJ0D)
(VALPROIC ACID - UNII:614OI1Z5WI) 		VALPROIC ACID100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM(UNII: 7FLD91C86K)0.4 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63323-494-1610 in 1 TRAY 18/08/2003
1NDC:63323-494-415 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076539 08/18/2003

LABELER - Fresenius Kabi USA, LLC (608775388)

Establishment
Name Address ID/FEI Business Operations
Fresenius Kabi USA, LLC 840771732 analysis(63323-494), manufacture(63323-494)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Valproate Sodium 5 mL SIngle Dose Vial Label

NDC 63323-494-41



Valproate Sodium

Injection, USP

500 mg* per 5 mL

(100 mg per mL)

For intravenous infusion only.

Preservative free.

5 mL Single-dose Vial Rx only

Vial label

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Valproate Sodium 5 mL Single Dose Vial Tray Label

NDC 63323-494-16



Valproate Sodium

Injection, USP

500 mg* per 5 mL

(100 mg per mL)

For intravenous infusion only.

Preservative free.

10 x 5 mL

Single-dose Vials Rx only

vial tray label