Duloxetine Hydrochloride 20 Mg (Page 13 of 13)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Duloxetine Delayed-Release Capsules 20 mg (30 Capsules in 1 Bottle)
Each capsule contains 22.4 mg of duloxetine hydrochloride equivaent to 20 mg duloxetine46708-128-30

20mg HDPE Bottle Pack
(click image for full-size original)

Duloxetine Delayed-Release Capsules 30 mg (30 Capsules in 1 Bottle)
Each capsule contains 33.7 mg of duloxetine hydrochloride equivaent to 30 mg duloxetine46708-129-30

30mg HDPE Bottle Pack
(click image for full-size original)

Duloxetine Delayed-Release Capsules 60 mg (30 Capsules in 1 Bottle)
Each capsule contains 67.3 mg of duloxetine hydrochloride equivaent to 60 mg duloxetine46708-130-30

60mg HDPE Bottle Pack
(click image for full-size original)
DULOXETINE HYDROCHLORIDE 20 MG duloxetine capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-128
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
HYPROMELLOSES
TALC
SUCROSE
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)
TRIETHYL CITRATE
TITANIUM DIOXIDE
FD&C BLUE NO. 2
GELATIN
SODIUM LAURYL SULFATE
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
AMMONIA
SHELLAC
POTASSIUM HYDROXIDE
Product Characteristics
Color GREEN (Opaque green) Score no score
Shape CAPSULE (CAPSULE) Size 14mm
Flavor Imprint Code 156;A
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-128-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:46708-128-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:46708-128-91 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
4 NDC:46708-128-10 100 CAPSULE, DELAYED RELEASE in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202949 06/09/2014
DULOXETINE HYDROCHLORIDE 30 MG duloxetine capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-129
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
HYPROMELLOSES
TALC
SUCROSE
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)
TRIETHYL CITRATE
TITANIUM DIOXIDE
FD&C BLUE NO. 2
GELATIN
SODIUM LAURYL SULFATE
AMMONIA
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color BLUE (Opaque blue) , WHITE (opaque white) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code 157;A
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-129-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:46708-129-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:46708-129-91 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
4 NDC:46708-129-10 100 CAPSULE, DELAYED RELEASE in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202949 06/09/2014
DULOXETINE HYDROCHLORIDE 60 MG duloxetine capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-130
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
HYPROMELLOSES
TALC
SUCROSE
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)
TRIETHYL CITRATE
TITANIUM DIOXIDE
FD&C BLUE NO. 2
GELATIN
SODIUM LAURYL SULFATE
FERRIC OXIDE YELLOW
POTASSIUM HYDROXIDE
AMMONIA
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color BLUE (Opaque blue) , GREEN (opaque green) Score no score
Shape CAPSULE (CAPSULE) Size 19mm
Flavor Imprint Code 158;A
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-130-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:46708-130-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:46708-130-91 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
4 NDC:46708-130-10 100 CAPSULE, DELAYED RELEASE in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202949 06/09/2014
Labeler — Alembic Pharmaceuticals Limited (650574663)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE (46708-128), MANUFACTURE (46708-129), MANUFACTURE (46708-130)

Revised: 06/2014 Alembic Pharmaceuticals Limited

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