NDC Code(s) : 61786-828-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

QuetiapineQuetiapine TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-828(NDC:0093-8163)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE(UNII: 2S3PL1B6UJ)
(QUETIAPINE - UNII:BGL0JSY5SI) 		QUETIAPINE200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(UNII: O7TSZ97GEP)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (50 MPA.S)(UNII: 1IVH67816N)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POVIDONE K25(UNII: K0KQV10C35)
POVIDONE K27(UNII: H7AGY1OJO8)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 11 mm
Flavor Imprint Code 93;8163
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-828-0230 in 1 BLISTER PACK Type 0: Not a Combination Product22/08/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077745 08/22/2016

PRINCIPAL DISPLAY PANEL

DRUG: Quetiapine

GENERIC: Quetiapine

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 61786-828-02

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 11 mm

IMPRINT: 93;8163

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • QUETIAPINE FUMARATE 200mg in 1

INACTIVE INGREDIENT(S):

  • MICROCRYSTALLINE CELLULOSE
  • POVIDONE K27
  • SODIUM STARCH GLYCOLATE TYPE A POTATO
  • POVIDONE K25
  • POLYDEXTROSE
  • TITANIUM DIOXIDE
  • TRIACETIN
  • POLYETHYLENE GLYCOL 8000
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE
  • HYPROMELLOSE 2910 (3 MPA.S)
  • HYPROMELLOSE 2910 (6 MPA.S)
  • MAGNESIUM STEARATE
  • HYPROMELLOSE 2910 (50 MPA.S)
  • LACTOSE MONOHYDRATE
  • SILICON DIOXIDE

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