Lamotrigine (Page 14 of 14)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

lamo
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LAMOTRIGINE lamotrigine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60760-474(NDC:68382-006)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 25 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color white (WHITE TO OFF- WHITE) Score 2 pieces
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code ZC;79
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60760-474-30 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077633 04/29/2021
Labeler — St. Mary’s Medical Park Pharmacy (063050751)
Establishment
Name Address ID/FEI Operations
St. Mary’s Medical Park Pharmacy 063050751 relabel (60760-474), repack (60760-474)

Revised: 05/2021 St. Mary’s Medical Park Pharmacy

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