Duloxetine Delayed-Release (Page 14 of 14)

DULOXETINE HYDROCHLORIDE

Label ImageLabel Image
DULOXETINE DELAYED-RELEASE duloxetine hydrochloride capsule, delayed release pellets
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-2226(NDC:51991-748)
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
TALC
TITANIUM DIOXIDE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
SODIUM LAURYL SULFATE
POLYSORBATE 80
TRIETHYL CITRATE
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
AMMONIA
POTASSIUM HYDROXIDE
SHELLAC
SUCROSE
STARCH, CORN
GELATIN, UNSPECIFIED
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
FERRIC OXIDE YELLOW
Product Characteristics
Color GREEN, YELLOW (Ochre) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code B;748
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-2226-0 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE None
2 NDC:50090-2226-1 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203088 06/11/2014
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-2226), REPACK (50090-2226)

Revised: 04/2021 A-S Medication Solutions

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