Prescription Drug Information: Duloxetine (Page 10 of 10)

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

Rising® NDC 57237-017-60

Duloxetine
Delayed-Release
Capsules USP
20 mg X 01
PHARMACIST: Dispense the Medication
Guide provided separately to each patient.
60 Capsules Rx only

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 20 mg (60 Capsules Bottle)
(click image for full-size original)

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

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

Rising® NDC 57237-018-30

Duloxetine
Delayed-Release
Capsules USP
30 mg X 02
PHARMACIST: Dispense the Medication
Guide provided separately to each patient.

30 Capsules Rx only

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 30 mg (30 Capsules Bottle)
(click image for full-size original)

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

Rising® NDC 57237-019-30

Duloxetine
Delayed-Release
Capsules USP
60 mg X 03
PHARMACIST: Dispense the Medication
Guide provided separately to each patient.
30 Capsules Rx only

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 60 mg (30 Capsules Bottle)
(click image for full-size original)

DULOXETINE duloxetine hydrochloride capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-017
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 (120 .MU.M)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)
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:57237-017-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:57237-017-99 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 12/11/2013
DULOXETINE duloxetine hydrochloride capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-018
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 (120 .MU.M)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)
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:57237-018-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:57237-018-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:57237-018-99 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 12/11/2013
DULOXETINE duloxetine hydrochloride capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-019
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 (120 .MU.M)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)
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:57237-019-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:57237-019-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:57237-019-99 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 12/11/2013
Labeler — Rising Health, LLC (080500961)
Registrant — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917642 ANALYSIS (57237-017), ANALYSIS (57237-018), ANALYSIS (57237-019), MANUFACTURE (57237-017), MANUFACTURE (57237-018), MANUFACTURE (57237-019)

Revised: 01/2021 Rising Health, LLC

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