Prescription Drug Information: Duloxetine (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68788-7672
Duloxetine delayed-release capsules
60 mg

Rx only

Ajanta Pharma Limited

Repackaged By: Preferred Pharmaceuticals Inc.PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Duloxetine Delayed-Release Cap USP 60mg
(click image for full-size original)
DULOXETINE duloxetine capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-7672(NDC:27241-099)
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
HYPROMELLOSE, UNSPECIFIED
SUCROSE
TALC
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 600000 MW)
TRIETHYL CITRATE
FD&C BLUE NO. 2
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
SHELLAC
ALCOHOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
WATER
Product Characteristics
Color WHITE, BLUE Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code DLX60;ap
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-7672-0 6 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:68788-7672-1 10 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:68788-7672-2 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
4 NDC:68788-7672-3 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
5 NDC:68788-7672-6 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
6 NDC:68788-7672-9 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
7 NDC:68788-7672-8 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208706 02/28/2020
Labeler — Preferred Pharmaceuticals, Inc. (791119022)
Registrant — Preferred Pharmaceuticals, Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals, Inc. 791119022 REPACK (68788-7672)

Revised: 05/2023 Preferred Pharmaceuticals, Inc.

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