Levetiracetam (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68382-165-19 in bottle of 120 tablets

Levetiracetam Tablets, 250 mg

120 tablets

Rx only

IMAGE
(click image for full-size original)

NDC 68382-168-14 in bottle of 60 tablets

Levetiracetam Tablets, 1000 mg

60 tablets

Rx only

image
(click image for full-size original)
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-165
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 250 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces
Shape OVAL (OVAL) Size 13mm
Flavor Imprint Code ZE;32
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-165-19 120 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68382-165-10 1000 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68382-165-30 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (68382-165-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078918 12/05/2017
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-168
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 1000 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces
Shape OVAL (OVAL) Size 21mm
Flavor Imprint Code ZE;35
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-168-14 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68382-168-10 1000 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68382-168-30 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (68382-168-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078918 12/05/2017
Labeler — Zydus Pharmaceuticals (USA) Inc. (156861945)
Registrant — Zydus Pharmaceuticals (USA) Inc. (156861945)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (68382-165), ANALYSIS (68382-168), MANUFACTURE (68382-165), MANUFACTURE (68382-168)

Revised: 12/2020 Zydus Pharmaceuticals (USA) Inc.

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