Duloxetine Hydrochloride (Page 15 of 15)

Duloxetine DR Caps 30mg

Duloxetine DR Caps 30mg bingo card label
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Duloxetine DR Caps 60mg

Duloxetine DR Caps 60mg bingo card label
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DULOXETINE HYDROCHLORIDE duloxetin hydrochloride capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-8203(NDC:13668-110)
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
FD&C RED NO. 40
GELATIN
HYPROMELLOSE 2910 (6 MPA.S)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
POLYETHYLENE GLYCOL 400
SODIUM LAURYL SULFATE
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color blue (blue cap and milky white body) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 30;1110
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0615-8203-39 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK None
2 NDC:0615-8203-05 15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090774 12/11/2013
DULOXETINE HYDROCHLORIDE duloxetin hydrochloride capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-8204(NDC:13668-111)
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. 2
GELATIN
HYPROMELLOSE 2910 (6 MPA.S)
FERRIC OXIDE YELLOW
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
POLYETHYLENE GLYCOL 400
SODIUM LAURYL SULFATE
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color blue (opaque blue cap and yellow body) Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code 60;1111
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0615-8204-05 15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK None
2 NDC:0615-8204-39 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090774 12/11/2013
Labeler — NCS HealthCare of KY, LLC dba Vangard Labs (050052943)
Establishment
Name Address ID/FEI Operations
NCS HealthCare of KY, LLC dba Vangard Labs 050052943 repack (0615-8203), repack (0615-8204)

Revised: 09/2022 NCS HealthCare of KY, LLC dba Vangard Labs

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