Cymbalta (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

Cymbalta®

Duloxetine HCl DELAYED RELEASE CAPSULES

20 mg

Each capsule contains 22.4 mg of duloxetine hydrochloride equivalent to 20 mg duloxetine.

Rx Only

www.Cymbalta.com

image of 20 mg package label
(click image for full-size original)

Cymbalta®

duloxetine HCl DELAYED RELEASE CAPSULES

30 mg

Each capsule contains 33.7 mg of duloxetine hydrochloride equivalent to 30 mg duloxetine.

Rx Only

www.Cymbalta.com

image of 30 mg package label
(click image for full-size original)

Cymbalta®

duloxetine HCl DELAYED RELEASE CAPSULES

60 mg

Each capsule contains 67.3 mg of duloxetine hydrochloride equivalent to 60 mg duloxetine.

Rx Only

www.Cymbalta.com

image of 60 mg package label
(click image for full-size original)
CYMBALTA duloxetine hydrochloride capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5215(NDC:0002-3235)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DULOXETINE HYDROCHLORIDE (DULOXETINE) DULOXETINE HYDROCHLORIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
HYPROMELLOSE
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)
SODIUM LAURYL SULFATE
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
Product Characteristics
Color green (opaque green) Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code LILLY;3235;20;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5215-0 60 CAPSULE, DELAYED RELEASE (CAPSULE) in 1 BOTTLE None
2 NDC:54868-5215-1 90 CAPSULE, DELAYED RELEASE (CAPSULE) in 1 BOTTLE None
3 NDC:54868-5215-2 30 CAPSULE, DELAYED RELEASE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021427 04/28/2008
CYMBALTA duloxetine hydrochloride capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5315(NDC:0002-3240)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DULOXETINE HYDROCHLORIDE (DULOXETINE) DULOXETINE HYDROCHLORIDE 30 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
HYPROMELLOSE
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)
SODIUM LAURYL SULFATE
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
FD&C BLUE NO. 2
Product Characteristics
Color blue (opaque blue) , white (opaque white) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code LILLY;3240;30;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5315-0 30 CAPSULE, DELAYED RELEASE (CAPSULE) in 1 BOTTLE None
2 NDC:54868-5315-1 90 CAPSULE, DELAYED RELEASE (CAPSULE) in 1 BOTTLE None
3 NDC:54868-5315-2 60 CAPSULE, DELAYED RELEASE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021427 11/21/2008
CYMBALTA duloxetine hydrochloride capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5192(NDC:0002-3237)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DULOXETINE HYDROCHLORIDE (DULOXETINE) DULOXETINE HYDROCHLORIDE 60 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
HYPROMELLOSE
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)
SODIUM LAURYL SULFATE
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
Product Characteristics
Color green (opaque green) , blue (opaque blue) Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code LILLY;3237;60;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5192-0 30 CAPSULE, DELAYED RELEASE (CAPSULE) in 1 BOTTLE None
2 NDC:54868-5192-1 90 CAPSULE, DELAYED RELEASE (CAPSULE) in 1 BOTTLE None
3 NDC:54868-5192-2 60 CAPSULE, DELAYED RELEASE (CAPSULE) in 1 BOTTLE None
4 NDC:54868-5192-3 180 CAPSULE, DELAYED RELEASE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021427 11/23/2009
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 repack, relabel

Revised: 11/2009 Physicians Total Care, Inc.

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