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

NDC 70771-1345-3

Duloxetine Delayed-release Capsules, 30mg

30 Capsules

Rx only

NDC 70771-1346-3

Duloxetine Delayed-release Capsules, 60mg

30 Capsules

Rx only

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