Duloxetine (Page 16 of 16)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 20 mg (60 Capsules Bottle)

BluePoint Laboratories NDC 68001-413-06
Duloxetine
Delayed-release
Capsules USP
20 mg X 01
PHARMACIST: Dispense the Medication
Guide provided separately to each patient.
60 Capsules Rx only

Duloxetine DR Capsules BluePoint rev 09 2019
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 30 mg (30 Capsules Bottle)

BluePoint Laboratories NDC 68001-414-04
Duloxetine
Delayed-release
Capsules USP
30 mg X 02
PHARMACIST: Dispense the Medication
Guide provided separately to each patient.
30 capsules Rx only

Duloxetine DR Capsules 30 mg rev 09 2019
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 60 mg (30 Capsules Bottle)

BluePoint Laboratories NDC 68001-415-04
Duloxetine
Delayed-release
Capsules USP
60 mg X 03
PHARMACIST: Dispense the Medication
Guide provided separately to each patient.
30 Capsules Rx only

Duloxetine DR Capsules USP rev 09 2019
(click image for full-size original)

DULOXETINE duloxetine hydrochloride capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-413
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)
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 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:68001-413-06 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090778 09/30/2019
DULOXETINE duloxetine hydrochloride capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-414
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)
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:68001-414-04 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:68001-414-05 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:68001-414-08 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090778 09/30/2019
DULOXETINE duloxetine hydrochloride capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-415
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)
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:68001-415-04 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:68001-415-05 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:68001-415-08 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090778 09/30/2019
Labeler — BluePoint Laboratories (985523874)
Registrant — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917642 ANALYSIS (68001-413), ANALYSIS (68001-414), ANALYSIS (68001-415), MANUFACTURE (68001-413), MANUFACTURE (68001-414), MANUFACTURE (68001-415)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917626 API MANUFACTURE (68001-413), API MANUFACTURE (68001-414), API MANUFACTURE (68001-415)

Revised: 06/2020 BluePoint Laboratories

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