Levetiracetam (Page 9 of 9)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 750 mg

Rising®
PHARMACEUTICALS

Repackaged By: Preferred Pharmaceuticals Inc.
NDC 68788-8577-9
Levetiracetam
Tablets USP
750 mg
PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED
SEPARATELY
120 Tablets Rx only

Levetiracetam Tab USP 500mg
(click image for full-size original)

LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-8577(NDC:16571-788)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 500 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
SILICON DIOXIDE
POVIDONE K30
TALC
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 4000
WATER
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL (Biconvex) Size 18mm
Flavor Imprint Code E;11
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-8577-9 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078993 02/01/2024
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK (68788-8577)

Revised: 02/2024 Preferred Pharmaceuticals Inc.

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