NDC Code(s) : 45865-836-60
Packager : medsource pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TelmisartanTelmisartan 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(UNII: U5SYW473RQ)
(TELMISARTAN - UNII:U5SYW473RQ) 		TELMISARTAN40 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
MEGLUMINE(UNII: 6HG8UB2MUY)
POVIDONE(UNII: FZ989GH94E)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color white (White to off white colour) Score no score
Shape OVAL Size 12 mm
Flavor Imprint Code L203
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:45865-836-6060 in 1 BOTTLE Type 0: Not a Combination Product06/01/2018
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 Business Operations
medsource pharmaceuticals 833685915 repack(45865-836)

PRINCIPAL DISPLAY PANEL

labelpdp