Duloxetine (Page 14 of 14)

PRINCIPAL DISPLAY PANEL — 20 mg Capsule Bottle Label

500 Capsules
NDC 82009-029-05

Duloxetine
Delayed-Release Capsules, USP

Rx Only

20 mg

PHARMACIST: Dispense the Medication Guide
provided separately to each patient.

QuallentPharmaceuticalsSM

PRINCIPAL DISPLAY PANEL -- 20 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30 mg Capsule Bottle Label

1,000 Capsules
NDC 82009-030-10

Duloxetine
Delayed-Release Capsules, USP

Rx Only

30 mg

PHARMACIST: Dispense the Medication Guide
provided separately to each patient.

QuallentPharmaceuticalsSM

PRINCIPAL DISPLAY PANEL -- 30 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 60 mg Capsule Bottle Label

1,000 Capsules
NDC 82009-032-10

Duloxetine
Delayed-Release Capsules, USP

Rx Only

60 mg

PHARMACIST: Dispense the Medication Guide
provided separately to each patient.

QuallentPharmaceuticalsSM

PRINCIPAL DISPLAY PANEL -- 60 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 40 mg Capsule Bottle Label

30 Capsules
NDC 82009-031-30

Duloxetine
Delayed-Release Capsules, USP

Rx Only

40 mg

PHARMACIST: Dispense the Medication Guide
provided separately to each patient.

QuallentPharmaceuticalsSM

PRINCIPAL DISPLAY PANEL -- 40 mg Capsule Bottle Label
(click image for full-size original)
DULOXETINE duloxetine hydrochloride capsule, delayed release pellets
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82009-029
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
TITANIUM DIOXIDE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
SODIUM LAURYL SULFATE
POLYSORBATE 80
TRIETHYL CITRATE
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
AMMONIA
POTASSIUM HYDROXIDE
SHELLAC
SUCROSE
STARCH, CORN
GELATIN, UNSPECIFIED
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW (Ochre) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code B;746
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82009-029-05 500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203088 06/11/2014
DULOXETINE duloxetine hydrochloride capsule, delayed release pellets
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82009-030
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
TITANIUM DIOXIDE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
SODIUM LAURYL SULFATE
POLYSORBATE 80
TRIETHYL CITRATE
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
AMMONIA
POTASSIUM HYDROXIDE
SHELLAC
SUCROSE
STARCH, CORN
GELATIN, UNSPECIFIED
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
Product Characteristics
Color GREEN, WHITE Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code B;747
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82009-030-10 1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203088 06/11/2014
DULOXETINE duloxetine hydrochloride capsule, delayed release pellets
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82009-032
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
TITANIUM DIOXIDE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
SODIUM LAURYL SULFATE
POLYSORBATE 80
TRIETHYL CITRATE
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
AMMONIA
POTASSIUM HYDROXIDE
SHELLAC
SUCROSE
STARCH, CORN
GELATIN, UNSPECIFIED
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
FERRIC OXIDE YELLOW
Product Characteristics
Color GREEN, YELLOW (ochre) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code B;748
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82009-032-10 1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203088 06/11/2014
DULOXETINE duloxetine hydrochloride capsule, delayed release pellets
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82009-031
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DULOXETINE HYDROCHLORIDE (DULOXETINE) DULOXETINE 40 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED
TALC
TITANIUM DIOXIDE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
SODIUM LAURYL SULFATE
POLYSORBATE 80
TRIETHYL CITRATE
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
AMMONIA
POTASSIUM HYDROXIDE
SHELLAC
SUCROSE
STARCH, CORN
GELATIN, UNSPECIFIED
FD&C BLUE NO. 2
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color ORANGE, BLUE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code B;750
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82009-031-30 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE None
2 NDC:82009-031-90 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203088 05/21/2018
Labeler — Quallent Pharmaceuticals Health, LLC (815564528)
Establishment
Name Address ID/FEI Operations
Towa Pharmaceutical Europe, S.L. 467833930 MANUFACTURE (82009-029), MANUFACTURE (82009-030), MANUFACTURE (82009-031), MANUFACTURE (82009-032)
Establishment
Name Address ID/FEI Operations
Apace Packaging LLC 361961142 PACK (82009-029), PACK (82009-030), PACK (82009-031), PACK (82009-032)

Revised: 01/2023 Quallent Pharmaceuticals Health, LLC

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