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

NDC 25000-609-03

Duloxetine Delayed-Release Capsules USP, 30 mg

30 count bottle label

NDC 25000-609-07

Duloxetine Delayed-Release Capsules USP, 30 mg

90 count bottle label

NDC 25000-610-03

Duloxetine Delayed-Release Capsules USP, 60 mg

30 count bottle label

NDC 25000-610-07

Duloxetine Delayed-Release Capsules USP, 60 mg

90 count bottle label

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