DULOXETINE HYDROCHLORIDE (Page 14 of 14)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 20 mg

NDC 46708-278-30
Duloxetine
Delayed-release
Capsules USP,
20 mg
PHARMACIST: Dispense the accompanying
Medication Guide to each patient.
Rx only
30 CapsulesAlembic

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 30 mg

NDC 46708-279-30
Duloxetine
Delayed-release
Capsules USP,
30 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.
Rx only
30 CapsulesAlembic

//medlibrary.org/lib/images-rx/duloxetine-hydrochloride-14/duloxetine-30mg-300x108.jpg
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duloxetine-30mg.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 60 mg

NDC 46708-280-30
Duloxetine
Delayed-release
Capsules USP,
60 mg
PHARMACIST: Dispense the accompanying
Medication Guide to each patient.
Rx only
30 Capsules
Alembic

//medlibrary.org/lib/images-rx/duloxetine-hydrochloride-14/duloxetine-60mg-300x122.jpg
(click image for full-size original)

DULOXETINE HYDROCHLORIDE duloxetine capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-278
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
HYPROMELLOSE, UNSPECIFIED
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:46708-278-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:46708-278-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:46708-278-91 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
4 NDC:46708-278-10 100 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 duloxetine capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-279
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
HYPROMELLOSE, UNSPECIFIED
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:46708-279-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:46708-279-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:46708-279-91 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
4 NDC:46708-279-10 100 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 duloxetine capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-280
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
HYPROMELLOSE, UNSPECIFIED
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:46708-280-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:46708-280-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:46708-280-91 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
4 NDC:46708-280-10 100 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 (46708-278), MANUFACTURE (46708-279), MANUFACTURE (46708-280)

Revised: 10/2020 Alembic Pharmaceuticals Limited

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