Levetiracetam (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 100 mg/mL Vial Carton

NDC 14335-050-10
10 single-use 5 mL vials


levetiracetam injection
500 mg/5 mL
(100 mg/mL)

Rx only

FOR INTRAVENOUS USE ONLY MUST BE DILUTED PRIOR TO ADMINISTRATION

Principal Display Panel -- 100 mg/mL Vial Carton
(click image for full-size original)

LEVETIRACETAM levetiracetam injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:14335-050
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM CHLORIDE
ACETIC ACID
SODIUM ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:14335-050-10 10 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
1 5 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (14335-050-10)
2 NDC:14335-050-25 25 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
2 5 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (14335-050-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209781 11/30/2018
Labeler — Hainan Poly Pharm. Co., Ltd. (654561638)
Establishment
Name Address ID/FEI Operations
Hainan Poly Pharm. Co., Ltd. 654561638 manufacture (14335-050), analysis (14335-050), label (14335-050), pack (14335-050)

Revised: 11/2018 Hainan Poly Pharm. Co., Ltd.

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