Fesoterodine Fumarate

FESOTERODINE FUMARATE- fesoterodine fumarate tablet, film coated, extended release
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1168-9 in bottle of 90 tablets

Fesoterodine Fumarate Extended-release Tablets, 4 mg

Rx only

90 tablets

Fesoterodine ER Tablets, 4 mg
(click image for full-size original)

NDC 70771-1169-9 in bottle of 90 tablets

Fesoterodine Fumarate Extended-release Tablets, 8 mg

Rx only

90 tablets

Fesoterodine ER Tablets, 8 mg
(click image for full-size original)
FESOTERODINE FUMARATE
fesoterodine fumarate tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1168
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FESOTERODINE FUMARATE (FESOTERODINE) FESOTERODINE FUMARATE 4 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYPROMELLOSES
LACTOSE MONOHYDRATE
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
TALC
TITANIUM DIOXIDE
XANTHAN GUM
FERRIC OXIDE YELLOW
POLYVINYL ALCOHOL, UNSPECIFIED
Product Characteristics
Color YELLOW (Light Yellow) Score no score
Shape OVAL (Oval) Size 13mm
Flavor Imprint Code 479
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1168-3 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70771-1168-9 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:70771-1168-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1168-2)
3 NDC:70771-1168-2 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (70771-1168-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204946 12/07/2017
FESOTERODINE FUMARATE
fesoterodine fumarate tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1169
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FESOTERODINE FUMARATE (FESOTERODINE) FESOTERODINE FUMARATE 8 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYPROMELLOSES
LACTOSE MONOHYDRATE
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
TALC
TITANIUM DIOXIDE
XANTHAN GUM
POLYVINYL ALCOHOL, UNSPECIFIED
Product Characteristics
Color WHITE (White to Off-White) Score no score
Shape OVAL (Oval) Size 13mm
Flavor Imprint Code 480
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1169-3 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70771-1169-9 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:70771-1169-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1169-2)
3 NDC:70771-1169-2 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (70771-1169-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204946 12/07/2017
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (70771-1168), ANALYSIS (70771-1169), MANUFACTURE (70771-1168), MANUFACTURE (70771-1169)

Revised: 08/2020 Cadila Healthcare Limited

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