Duloxetine (Page 14 of 14)

Package/Label Display Panel

Duloxetine Delayed-Release Capsules USP

20 mg

100 Capsules

carton label
(click image for full-size original)

Package/Label Display Panel

Duloxetine Delayed-Release Capsules USP

30 mg

100 Capsules

carton label
(click image for full-size original)

Package/Label Display Panel

Duloxetine Delayed-Release Capsules USP

60 mg

100 Capsules

carton label
(click image for full-size original)
DULOXETINE duloxetine hydrochloride capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-7044(NDC:57237-018)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DULOXETINE HYDROCHLORIDE (DULOXETINE) DULOXETINE 30 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
FD&C BLUE NO. 2
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
AMMONIA
Product Characteristics
Color BLUE (Blue Opaque) , WHITE (White Opaque) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code X;02
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-7044-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (0904-7044-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090778 12/11/2013
DULOXETINE duloxetine hydrochloride capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-7045(NDC:57237-019)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DULOXETINE HYDROCHLORIDE (DULOXETINE) DULOXETINE 60 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
AMMONIA
Product Characteristics
Color BLUE (Blue Opaque) , GREEN (Green Opaque) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code X;03
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-7045-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (0904-7045-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090778 12/11/2013
DULOXETINE duloxetine hydrochloride capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-7043(NDC:57237-017)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DULOXETINE HYDROCHLORIDE (DULOXETINE) DULOXETINE 20 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
AMMONIA
Product Characteristics
Color GREEN (Green Opaque) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code X;01
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-7043-04 30 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (0904-7043-04)
2 NDC:0904-7043-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (0904-7043-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090778 12/11/2013
Labeler — Major Pharmaceuticals (191427277)

Revised: 06/2021 Major Pharmaceuticals

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.