Duloxetine

DULOXETINE- duloxetine hydrochloride capsule, delayed release
Cadila Healthcare Limited

Manufactured by:

Cadila Healthcare Ltd.

India.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1344-3

Duloxetine Delayed-release Capsules, 20mg

30 Capsules

Rx only

Duloxetine delayed-release capsules
(click image for full-size original)

NDC 70771-1345-3

Duloxetine Delayed-release Capsules, 30mg

30 Capsules

Rx only

Duloxetine delayed-release capsules
(click image for full-size original)

NDC 70771-1346-3

Duloxetine Delayed-release Capsules, 60mg

30 Capsules

Rx only

Duloxetine delayed-release capsules
(click image for full-size original)
DULOXETINE
duloxetine capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1344
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
ALCOHOL
AMMONIA
BUTYL ALCOHOL
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
FERRIC OXIDE YELLOW
GELATIN
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)
HYPROMELLOSES
ISOPROPYL ALCOHOL
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
STARCH, CORN
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color GREEN (GREEN) , WHITE (WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 14mm
Flavor Imprint Code 385;20;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1344-3 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:70771-1344-6 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:70771-1344-9 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
4 NDC:70771-1344-0 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090728 05/27/2014
DULOXETINE
duloxetine capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1345
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
FD&C BLUE NO. 1
GELATIN
HYPROMELLOSES
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)
SODIUM LAURYL SULFATE
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
D&C YELLOW NO. 10
FD&C RED NO. 40
FD&C YELLOW NO. 6
BUTYL ALCOHOL
ALCOHOL
ISOPROPYL ALCOHOL
PROPYLENE GLYCOL
SHELLAC
AMMONIA
FERRIC OXIDE YELLOW
STARCH, CORN
Product Characteristics
Color BLUE (BLUE) , GREEN (GREEN) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code 386;30;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1345-3 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:70771-1345-9 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:70771-1345-0 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090728 05/27/2014
DULOXETINE
duloxetine capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1346
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
FD&C BLUE NO. 1
GELATIN
HYPROMELLOSES
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)
SODIUM LAURYL SULFATE
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
FD&C RED NO. 40
BUTYL ALCOHOL
ALCOHOL
ISOPROPYL ALCOHOL
PROPYLENE GLYCOL
SHELLAC
AMMONIA
FERRIC OXIDE YELLOW
STARCH, CORN
Product Characteristics
Color BLUE (BLUE) , WHITE (WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 19mm
Flavor Imprint Code 387;60;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1346-3 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:70771-1346-9 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:70771-1346-0 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090728 05/27/2014
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (70771-1344), ANALYSIS (70771-1345), ANALYSIS (70771-1346), MANUFACTURE (70771-1344), MANUFACTURE (70771-1345), MANUFACTURE (70771-1346)

Revised: 08/2020 Cadila Healthcare Limited

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