NDC Code(s) : 70518-0859-0, 70518-0859-1
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:70518-0859(NDC:68180-319)
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
AMMONIA(UNII: 5138Q19F1X)
CYSTEINE HYDROCHLORIDE(UNII: ZT934N0X4W)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GLYCERYL BEHENATE/EICOSADIOATE(UNII: 73CJJ317SR)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
POVIDONE(UNII: FZ989GH94E)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SILICA DIMETHYL SILYLATE(UNII: EU2PSP0G0W)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color white (off-white to pale yellow) Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code L015
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70518-0859-030 in 1 BLISTER PACK Type 0: Not a Combination Product20/11/2017
2NDC:70518-0859-130 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product30/11/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090693 11/20/2017

LABELER - REMEDYREPACK INC.(829572556)

PRINCIPAL DISPLAY PANEL

DRUG: Bupropion Hydrochloride

GENERIC: Bupropion Hydrochloride

DOSAGE: TABLET, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-0859-0

NDC: 70518-0859-1

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 7 mm

IMPRINT: L015

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 30 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

  • BUPROPION HYDROCHLORIDE 150mg in 1

INACTIVE INGREDIENT(S):

  • AMMONIA
  • CYSTEINE HYDROCHLORIDE
  • DIBUTYL SEBACATE
  • ETHYLCELLULOSES
  • FERROSOFERRIC OXIDE
  • GLYCERYL BEHENATE/EICOSADIOATE
  • HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
  • METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
  • POLYVINYL ALCOHOL, UNSPECIFIED
  • POVIDONE
  • PROPYLENE GLYCOL
  • SHELLAC
  • SILICA DIMETHYL SILYLATE
  • SILICON DIOXIDE
  • TRIETHYL CITRATE

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