NDC Code(s) : 61786-534-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bupropion HydrochlorideBupropion Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-534(NDC:45963-141)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O)
(BUPROPION - UNII:01ZG3TPX31) 		BUPROPION HYDROCHLORIDE150 mg
Inactive Ingredients
Ingredient Name Strength
COPOVIDONE(UNII: D9C330MD8B)
HYDROXYPROPYL CELLULOSE (1200000 MW)(UNII: RFW2ET671P)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TALC(UNII: 7SEV7J4R1U)
METHACRYLIC ACID(UNII: 1CS02G8656)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Product Characteristics
Color white (off white) Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code 141
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-534-0230 in 1 BOTTLE Type 0: Not a Combination Product15/02/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077285 02/15/2016

PRINCIPAL DISPLAY PANEL

DRUG: Bupropion Hydrochloride

GENERIC: Bupropion Hydrochloride

DOSAGE: TABLET, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 61786-534-02

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 8 mm

IMPRINT: 141

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • BUPROPION HYDROCHLORIDE 150mg in 1

INACTIVE INGREDIENT(S):

  • COPOVIDONE
  • METHACRYLIC ACID
  • TRIETHYL CITRATE
  • SODIUM BICARBONATE
  • POVIDONE, UNSPECIFIED
  • SODIUM LAURYL SULFATE
  • TALC
  • HYDROCHLORIC ACID
  • HYDROXYPROPYL CELLULOSE (1200000 MW)
  • SILICON DIOXIDE
  • MAGNESIUM STEARATE
  • POLYETHYLENE GLYCOL, UNSPECIFIED
  • POLYVINYL ALCOHOL, UNSPECIFIED
  • TITANIUM DIOXIDE

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