Duloxetine (Page 18 of 18)

PRINCIPAL DISPLAY PANEL — 30 mg

NDC 42292-020-20

Duloxetine
Delayed-release
Capsules, USP
30 mg

100 Capsules (10 x 10)

Each delayed-release capsule contains:
33.7 mg of duloxetine hydrochloride USP
equivalent to 30 mg duloxetine.

Usual Dosage: See accompanying
prescribing information and Medication Guide.

Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]

Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 090, India M.L.No.: 19/HD/AP/95/F/R

Rx only

S-12338

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Duloxetine Delayed-release 30 mg Capsules Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 60 mg

NDC 42292-021-20

Duloxetine
Delayed-release
Capsules, USP
60 mg

100 Capsules (10 x 10)

Each delayed-release capsule contains:
67.3 mg of duloxetine hydrochloride USP
equivalent to 60 mg duloxetine.

Usual Dosage: See accompanying
prescribing information and Medication Guide.

Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]

Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 090, India M.L.No.: 19/HD/AP/95/F/R

Rx only

S-12340

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Duloxetine Delayed-release 60 mg Capsules Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)
DULOXETINE duloxetine hydrochloride capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42292-020(NDC:65862-452)
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, UNSPECIFIED
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)
METHYLENE CHLORIDE
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:42292-020-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (42292-020-01)
1 NDC:42292-020-01 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (42292-020-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090778 12/13/2016 07/31/2019
DULOXETINE duloxetine hydrochloride capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42292-021(NDC:65862-453)
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, UNSPECIFIED
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)
METHYLENE CHLORIDE
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:42292-021-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (42292-021-01)
1 NDC:42292-021-01 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (42292-021-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090778 12/09/2016 03/31/2019
Labeler — Mylan Institutional Inc. (039615992)

Revised: 01/2019 Mylan Institutional Inc.

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