NDC Code(s) : 61786-935-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DuloxetineDuloxetine Hydrochloride CAPSULE, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-935(NDC:57237-018)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DULOXETINE HYDROCHLORIDE(UNII: 9044SC542W)
(DULOXETINE - UNII:O5TNM5N07U) 		DULOXETINE30 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE(UNII: 68401960MK)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(UNII: 87Y6436BKR)
METHYLENE CHLORIDE(UNII: 588X2YUY0A)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
GELATIN(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
AMMONIA(UNII: 5138Q19F1X)
Product Characteristics
Color blue (Blue Opaque), white (White Opaque) Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code X;02
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-935-0230 in 1 BLISTER PACK Type 0: Not a Combination Product10/11/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090778 10/11/2016

PRINCIPAL DISPLAY PANEL

DRUG: Duloxetine

GENERIC: Duloxetine Hydrochloride

DOSAGE: CAPSULE, DELAYED RELEASE

ADMINSTRATION: ORAL

NDC: 61786-935-02

COLOR: blue

SHAPE: CAPSULE

SCORE: No score

SIZE: 16 mm

IMPRINT: X;02

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • DULOXETINE HYDROCHLORIDE 30mg in 1

INACTIVE INGREDIENT(S):

  • AMMONIA
  • FD&C BLUE NO. 2
  • FERROSOFERRIC OXIDE
  • SODIUM LAURYL SULFATE
  • GELATIN
  • SHELLAC
  • POTASSIUM HYDROXIDE
  • PROPYLENE GLYCOL
  • CROSPOVIDONE
  • HYDROXYPROPYL CELLULOSE (TYPE H)
  • HYPROMELLOSE 2910 (5 MPA.S)
  • HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)
  • METHYLENE CHLORIDE
  • SUCROSE
  • TALC
  • TITANIUM DIOXIDE
  • TRIETHYL CITRATE

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