Duloxetine Delayed-Release (Page 15 of 15)

Principal Display Panel

NDC: 70934-729-30

Label
(click image for full-size original)
DULOXETINE DELAYED-RELEASE duloxetine hydrochloride capsule, delayed release pellets
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70934-729(NDC:51991-747)
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
HYPROMELLOSE, UNSPECIFIED
TALC
TITANIUM DIOXIDE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
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
Product Characteristics
Color green, white Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code B;747
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70934-729-30 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203088 08/14/2020
Labeler — Denton Pharma, Inc. dba Northwind Pharmaceuticals (080355546)
Registrant — Denton Pharma, Inc. dba Northwind Pharmaceuticals (080355546)
Establishment
Name Address ID/FEI Operations
Denton Pharma, Inc. dba Northwind Pharmaceuticals 080355546 repack (70934-729)

Revised: 08/2021 Denton Pharma, Inc. dba Northwind Pharmaceuticals

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