NDC Code(s) : 61786-321-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Quetiapine fumarateQuetiapine fumarate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-321(NDC:47335-906)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE(UNII: 2S3PL1B6UJ)
(QUETIAPINE - UNII:BGL0JSY5SI) 		QUETIAPINE300 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
CROSPOVIDONE(UNII: 68401960MK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white Score no score
Shape CAPSULE (TABLET, FILM COATED) Size 16 mm
Flavor Imprint Code 906
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-321-0230 in 1 BLISTER PACK Type 0: Not a Combination Product29/05/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201190 05/29/2015 03/29/2017

PRINCIPAL DISPLAY PANEL

DRUG: Quetiapine fumarate


GENERIC: Quetiapine fumarate


DOSAGE: TABLET, FILM COATED


ADMINSTRATION: ORAL


NDC: 61786-321-02


ACTIVE INGREDIENT(S):

  • QUETIAPINE FUMARATE 300mg in 1


INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • LACTOSE MONOHYDRATE
  • HYPROMELLOSE 2910 (6 MPA.S)
  • MAGNESIUM STEARATE
  • POLYETHYLENE GLYCOL 4000
  • CROSPOVIDONE
  • SILICON DIOXIDE
  • POLYSORBATE 80
  • ANHYDROUS CITRIC ACID
  • TITANIUM DIOXIDE


COLOR: white


SHAPE: CAPSULE


SCORE: No score


SIZE: 16 mm


IMPRINT: 906


PACKAGING: 30 in 1 BLISTER PACK




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