Darifenacin (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69097-431-02 Rx ONLY

Darifenacin

Extended Release

Tablets

7.5 mg*

Cipla 30 Tablets

image
(click image for full-size original)

NDC 69097-432-02 Rx ONLY

Darifenacin

Extended Release

Tablets

15 mg*

Cipla 30 Tablets

image
(click image for full-size original)
DARIFENACIN darifenacin hydrobromide tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-431
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DARIFENACIN HYDROBROMIDE (DARIFENACIN) DARIFENACIN 7.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
HYPROMELLOSE 2910 (3 MPA.S)
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 4000
Product Characteristics
Color WHITE ((off-white)) Score no score
Shape ROUND (circular biconvex) Size 8mm
Flavor Imprint Code C;431
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69097-431-02 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:69097-431-05 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:69097-431-15 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207664 09/01/2016
DARIFENACIN darifenacin hydrobromide tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-432
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DARIFENACIN HYDROBROMIDE (DARIFENACIN) DARIFENACIN 15 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
HYPROMELLOSE 2910 (3 MPA.S)
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 4000
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color ORANGE ((light peach)) Score no score
Shape ROUND (circular biconvex) Size 8mm
Flavor Imprint Code C;432
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69097-432-02 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:69097-432-05 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:69097-432-15 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207664 09/01/2016
Labeler — Cipla USA Inc. (078719707)
Registrant — Cipla USA Inc. (078719707)
Establishment
Name Address ID/FEI Operations
Cipla Ltd. Patalganga unit II 916940208 ANALYSIS (69097-431), ANALYSIS (69097-432), LABEL (69097-431), LABEL (69097-432), MANUFACTURE (69097-431), MANUFACTURE (69097-432), PACK (69097-431), PACK (69097-432)

Revised: 08/2021 Cipla USA Inc.

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