NDC Code(s) : 62135-535-30, 62135-536-30, 62135-537-30
Packager : Chartwell RX, LLC.

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:62135-535
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TELMISARTAN(UNII: U5SYW473RQ)
(TELMISARTAN - UNII:U5SYW473RQ) 		TELMISARTAN20 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
MEGLUMINE(UNII: 6HG8UB2MUY)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND (circular) Size 7 mm
Flavor Imprint Code 20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62135-535-3030 in 1 BOTTLE Type 0: Not a Combination Product03/08/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078710 11/23/2020
TELMISARTANTELMISARTAN TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62135-536
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
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
MEGLUMINE(UNII: 6HG8UB2MUY)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Product Characteristics
Color white (white to off-white) Score no score
Shape CAPSULE Size 12 mm
Flavor Imprint Code 40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62135-536-3030 in 1 BOTTLE Type 0: Not a Combination Product03/08/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078710 11/23/2020
TELMISARTANTELMISARTAN TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62135-537
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TELMISARTAN(UNII: U5SYW473RQ)
(TELMISARTAN - UNII:U5SYW473RQ) 		TELMISARTAN80 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
MEGLUMINE(UNII: 6HG8UB2MUY)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Product Characteristics
Color white (white to off-white) Score no score
Shape CAPSULE Size 15 mm
Flavor Imprint Code 80
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62135-537-3030 in 1 BOTTLE Type 0: Not a Combination Product03/08/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078710 11/23/2020

LABELER - Chartwell RX, LLC.(079394054)

PRINCIPAL DISPLAY PANEL


Telmisartan Tablets, USP 20mg- NDC 62135-535-30- 30's Bottle Label

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Telmisartan Tablets, USP 40mg- NDC 62135-536-30- 30's Bottle Label

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Telmisartan Tablets, USP 80mg- NDC 62135-537-30- 30's Bottle Label

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