Duloxetine (Page 16 of 16)

DULOXETINE

Label ImageLabel Image
DULOXETINE duloxetine capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-6040(NDC:31722-582)
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
CROSPOVIDONE (15 MPA.S AT 5%)
GELATIN, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
ISOPROPYL ALCOHOL
POLYSORBATE 80
POVIDONE, UNSPECIFIED
SODIUM LAURYL SULFATE
SUCROSE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2
BUTYL ALCOHOL
PROPYLENE GLYCOL
SHELLAC
AMMONIA
ALCOHOL
METHYLCELLULOSE (4000 MPA.S)
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color BLUE (Blue opaque) , WHITE (White opaque) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code H;191
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-6040-0 33 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the BOX (50090-6040-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204343 08/11/2016
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-6040), REPACK (50090-6040)

Revised: 07/2022 A-S Medication Solutions

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