Telmisartan (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labelpdp
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TELMISARTAN telmisartan tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45865-836(NDC:62332-088)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TELMISARTAN (TELMISARTAN) TELMISARTAN 40 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
SODIUM HYDROXIDE
MEGLUMINE
POVIDONE
SODIUM STEARYL FUMARATE
MAGNESIUM STEARATE
Product Characteristics
Color white (White to off white colour) Score no score
Shape OVAL Size 12mm
Flavor Imprint Code L203
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45865-836-60 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202130 06/25/2016
Labeler — medsource pharmaceuticals (833685915)
Establishment
Name Address ID/FEI Operations
medsource pharmaceuticals 833685915 repack (45865-836)

Revised: 12/2018 medsource pharmaceuticals

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