Telmisartan (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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TELMISARTAN telmisartan tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-2591(NDC:67877-484)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TELMISARTAN (TELMISARTAN) TELMISARTAN 80 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MANNITOL
MEGLUMINE
POVIDONE
SODIUM HYDROXIDE
SODIUM STEARYL FUMARATE
Product Characteristics
Color white (white or off-white) Score no score
Shape OVAL Size 16mm
Flavor Imprint Code 038
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-2591-3 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205150 06/12/2016
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 relabel (68071-2591)

Revised: 07/2023 NuCare Pharmaceuticals,Inc.

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