Duloxetine (Page 12 of 12)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68788-7828

Rx Only

Duloxetine Delayd-Release Cap USP 30mg
(click image for full-size original)
DULOXETINE duloxetine capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-7828(NDC:67877-264)
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
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
CROSPOVIDONE (15 MPA.S AT 5%)
TALC
TRIETHYL CITRATE
TITANIUM DIOXIDE
ISOPROPYL ALCOHOL
METHYLENE CHLORIDE
FD&C BLUE NO. 2
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)
HYPROMELLOSE, UNSPECIFIED
SHELLAC
ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
POTASSIUM HYDROXIDE
SUCROSE
FERROSOFERRIC OXIDE
Product Characteristics
Color WHITE (WHITE) , BLUE (BLUE) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code Dulox;30mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-7828-0 6 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:68788-7828-1 10 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:68788-7828-2 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
4 NDC:68788-7828-3 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
5 NDC:68788-7828-6 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
6 NDC:68788-7828-9 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203197 01/08/2021
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK (68788-7828)

Revised: 01/2021 Preferred Pharmaceuticals Inc.

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