Telmisartan (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65162-291-03

Telmisartan Tablets USP, 20 mg

Rx only

30 Tablets

Amneal Pharmaceuticals

10
(click image for full-size original)

Carton and Blister Labels

NDC 65162-291-63

Telmisartan Tablets USP, 20 mg

Rx only

30 Tablets

Amneal Pharmaceuticals

10
(click image for full-size original)

10
(click image for full-size original)

NDC 65162-292-03

Telmisartan Tablets USP, 40 mg

Rx only

30 Tablets

Amneal Pharmaceuticals

10
(click image for full-size original)

Carton and Blister Labels

NDC 65162-292-63

Telmisartan Tablets USP, 40 mg

Rx only

30 Tablets

Amneal Pharmaceuticals

30
(click image for full-size original)

10
(click image for full-size original)

NDC 65162-293-03

Telmisartan Tablets USP, 80 mg

Rx only

30 Tablets

Amneal Pharmaceuticals

10
(click image for full-size original)

Carton and Blister Labels

NDC 65162-293-63

Telmisartan Tablets USP, 80 mg

Rx only

30 Tablets

Amneal Pharmaceuticals

10
(click image for full-size original)
10
(click image for full-size original)
TELMISARTAN
telmisartan tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-291
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TELMISARTAN (TELMISARTAN) TELMISARTAN 20 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MANNITOL
MEGLUMINE
POVIDONE
SODIUM HYDROXIDE
TALC
Product Characteristics
Color white (off-white) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code AN;291
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-291-03 30 TABLET in 1 BOTTLE None
2 NDC:65162-291-09 90 TABLET in 1 BOTTLE None
3 NDC:65162-291-50 500 TABLET in 1 BOTTLE None
4 NDC:65162-291-63 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65162-291-63)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204415 05/31/2013
TELMISARTAN
telmisartan tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-292
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
MAGNESIUM STEARATE
MANNITOL
MEGLUMINE
POVIDONE
SODIUM HYDROXIDE
TALC
Product Characteristics
Color white (off-white) Score no score
Shape CAPSULE Size 12mm
Flavor Imprint Code AN;292
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-292-03 30 TABLET in 1 BOTTLE None
2 NDC:65162-292-09 90 TABLET in 1 BOTTLE None
3 NDC:65162-292-50 500 TABLET in 1 BOTTLE None
4 NDC:65162-292-11 1000 TABLET in 1 BOTTLE None
5 NDC:65162-292-63 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65162-292-63)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204415 05/31/2013
TELMISARTAN
telmisartan tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-293
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
TALC
Product Characteristics
Color white (off-white) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code AN293
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-293-03 30 TABLET in 1 BOTTLE None
2 NDC:65162-293-09 90 TABLET in 1 BOTTLE None
3 NDC:65162-293-50 500 TABLET in 1 BOTTLE None
4 NDC:65162-293-11 1000 TABLET in 1 BOTTLE None
5 NDC:65162-293-63 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65162-293-63)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204415 05/31/2013
Labeler — Amneal Pharmaceuticals LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals Private Limited 915076126 analysis (65162-291), analysis (65162-292), analysis (65162-293), label (65162-291), label (65162-292), label (65162-293), manufacture (65162-291), manufacture (65162-292), manufacture (65162-293), pack (65162-291), pack (65162-292), pack (65162-293)

Revised: 02/2018 Amneal Pharmaceuticals LLC

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