NDC Code(s) : 70010-784-03, 70010-784-09, 70010-784-05, 70010-785-03, 70010-785-09, 70010-785-05
Packager : Granules Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bupropion hydrochlorideBupropion hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70010-784
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
ALCOHOL(UNII: 3K9958V90M)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
HYPROMELLOSES(UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
POLYCARBOPHIL(UNII: W25LM17A4W)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL(UNII: 532B59J990)
POVIDONE(UNII: FZ989GH94E)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color white (creamy-white to pale yellow) Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code G;784
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70010-784-0330 in 1 BOTTLE Type 0: Not a Combination Product15/12/2022
2NDC:70010-784-0990 in 1 BOTTLE Type 0: Not a Combination Product15/12/2022
3NDC:70010-784-05500 in 1 BOTTLE Type 0: Not a Combination Product15/12/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215568 12/15/2022
Bupropion hydrochlorideBupropion hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70010-785
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O)
(BUPROPION - UNII:01ZG3TPX31) 		BUPROPION HYDROCHLORIDE300 mg
Inactive Ingredients
Ingredient Name Strength
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
ALCOHOL(UNII: 3K9958V90M)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
HYPROMELLOSES(UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
POLYCARBOPHIL(UNII: W25LM17A4W)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL(UNII: 532B59J990)
POVIDONE(UNII: FZ989GH94E)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color white (creamy-white to pale yellow) Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code G;785
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70010-785-0330 in 1 BOTTLE Type 0: Not a Combination Product15/12/2022
2NDC:70010-785-0990 in 1 BOTTLE Type 0: Not a Combination Product15/12/2022
3NDC:70010-785-05500 in 1 BOTTLE Type 0: Not a Combination Product15/12/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215568 12/15/2022

LABELER - Granules Pharmaceuticals Inc.(079825711)

Establishment
Name Address ID/FEI Business Operations
Granules Pharmaceuticals Inc. 079825711 analysis(70010-784, 70010-785), manufacture(70010-784, 70010-785)

PRINCIPAL DISPLAY PANEL

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