Duloxetine (Page 14 of 14)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 25000-608-06

Duloxetine Delayed-Release Capsules USP, 20 mg

60 count bottle label

dulo-20mg-60s
(click image for full-size original)

NDC 25000-609-03

Duloxetine Delayed-Release Capsules USP, 30 mg

30 count bottle label

dulo-30mg-30s
(click image for full-size original)

NDC 25000-609-07

Duloxetine Delayed-Release Capsules USP, 30 mg

90 count bottle label

dulo-30mg-90s
(click image for full-size original)

NDC 25000-610-03

Duloxetine Delayed-Release Capsules USP, 60 mg

30 count bottle label

dulo-60mg-30s
(click image for full-size original)

NDC 25000-610-07

Duloxetine Delayed-Release Capsules USP, 60 mg

90 count bottle label

dulo-60mg-90s
(click image for full-size original)
DULOXETINE duloxetine hydrochloride capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25000-608
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
HYPROMELLOSES
GLYCINE
SUCROSE
TALC
TRIETHYL CITRATE
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 2
SHELLAC
POTASSIUM HYDROXIDE
SODIUM LAURYL SULFATE
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)
FERRIC OXIDE YELLOW
STARCH, CORN
FERROSOFERRIC OXIDE
Product Characteristics
Color GREEN (opaque green) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code RDY608;20mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-608-06 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090723 05/27/2022
DULOXETINE duloxetine hydrochloride capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25000-609
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
HYPROMELLOSES
GLYCINE
SUCROSE
TALC
TRIETHYL CITRATE
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 2
SHELLAC
SODIUM LAURYL SULFATE
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)
STARCH, CORN
FERRIC OXIDE YELLOW
Product Characteristics
Color BLUE (opaque blue) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code RDY609;30mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-609-03 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:25000-609-07 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090723 05/27/2022
DULOXETINE duloxetine hydrochloride capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25000-610
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
HYPROMELLOSES
GLYCINE
SUCROSE
TALC
TRIETHYL CITRATE
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 2
SHELLAC
SODIUM LAURYL SULFATE
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)
STARCH, CORN
FERRIC OXIDE YELLOW
POTASSIUM HYDROXIDE
Product Characteristics
Color BLUE (opaque blue) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code RDY610;60mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-610-03 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:25000-610-07 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090723 05/27/2022
Labeler — MARKSANS PHARMA LIMITED (925822975)
Establishment
Name Address ID/FEI Operations
MARKSANS PHARMA LIMITED 925822975 MANUFACTURE (25000-608), MANUFACTURE (25000-609), MANUFACTURE (25000-610)

Revised: 05/2022 MARKSANS PHARMA LIMITED

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