NDC Code(s) : 61786-676-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bupropion HydrochlorideBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-676(NDC:0115-5445)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O)
(BUPROPION - UNII:01ZG3TPX31) 		BUPROPION HYDROCHLORIDE200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (50 MPA.S)(UNII: 1IVH67816N)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POLYDEXTROSE(UNII: VH2XOU12IE)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color orange Score no score
Shape ROUND (convex) Size 6 mm
Flavor Imprint Code 555
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-676-0230 in 1 BOTTLE Type 0: Not a Combination Product25/04/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076711 04/25/2016 06/01/2016

PRINCIPAL DISPLAY PANEL

DRUG: Bupropion Hydrochloride

GENERIC: BUPROPION HYDROCHLORIDE

DOSAGE: TABLET, FILM COATED, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 61786-676-02

COLOR: orange

SHAPE: ROUND

SCORE: No score

SIZE: 6 mm

IMPRINT: 555

PACKAGING: 30 in 1 BOTTLE

ACTIVE INGREDIENT(S):

  • BUPROPION HYDROCHLORIDE 200mg in 1

INACTIVE INGREDIENT(S):

  • HYPROMELLOSE 2910 (3 MPA.S)
  • HYPROMELLOSE 2910 (50 MPA.S)
  • POLYETHYLENE GLYCOLS
  • HYPROMELLOSE 2910 (6 MPA.S)
  • POLYDEXTROSE
  • TITANIUM DIOXIDE
  • CELLULOSE, MICROCRYSTALLINE
  • HYDROXYPROPYL CELLULOSE (TYPE H)
  • MAGNESIUM STEARATE
  • FD&C YELLOW NO. 6
  • SILICON DIOXIDE
  • TRIACETIN

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