NDC Code(s) : 58657-710-30, 58657-710-90, 58657-710-50, 58657-711-30, 58657-711-90, 58657-711-50
Packager : Method Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bupropion hydrochloride Bupropion hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58657-710
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
ETHYLCELLULOSE (100 MPA.S)(UNII: 47MLB0F1MV)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
HYDROCHLORIC ACID(UNII: QTT17582CB)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 1450(UNII: OJ4Z5Z32L4)
POVIDONE K90(UNII: RDH86HJV5Z)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
TRIACETIN(UNII: XHX3C3X673)
TALC(UNII: 7SEV7J4R1U)
SHELLAC(UNII: 46N107B71O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
AMMONIA(UNII: 5138Q19F1X)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
METHYLENE CHLORIDE(UNII: 588X2YUY0A)
Product Characteristics
Color white (white to pale yellow) Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code 188
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58657-710-3030 in 1 BOTTLE Type 0: Not a Combination Product28/01/2019
2NDC:58657-710-9090 in 1 BOTTLE Type 0: Not a Combination Product28/01/2019
3NDC:58657-710-50500 in 1 BOTTLE Type 0: Not a Combination Product28/01/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211020 01/28/2019
Bupropion hydrochloride Bupropion hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58657-711
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
ETHYLCELLULOSE (100 MPA.S)(UNII: 47MLB0F1MV)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
HYDROCHLORIC ACID(UNII: QTT17582CB)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 1450(UNII: OJ4Z5Z32L4)
POVIDONE K90(UNII: RDH86HJV5Z)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
TRIACETIN(UNII: XHX3C3X673)
TALC(UNII: 7SEV7J4R1U)
SHELLAC(UNII: 46N107B71O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
AMMONIA(UNII: 5138Q19F1X)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
METHYLENE CHLORIDE(UNII: 588X2YUY0A)
Product Characteristics
Color white (white to pale yellow) Score no score
Shape ROUND (biconvex coated) Size 9 mm
Flavor Imprint Code 189
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58657-711-3030 in 1 BOTTLE Type 0: Not a Combination Product28/01/2019
2NDC:58657-711-9090 in 1 BOTTLE Type 0: Not a Combination Product28/01/2019
3NDC:58657-711-50500 in 1 BOTTLE Type 0: Not a Combination Product28/01/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211020 01/28/2019

LABELER - Method Pharmaceuticals, LLC(060216698)

PRINCIPAL DISPLAY PANEL

ONCE-DAILY

NDC 58657-710-30

buPROPion Hydrochloride Extended-Release Tablets, USP (XL)

150 mg

WARNING: Do not use in combination with Zyban or any other medicines that contain bupropion hydrochloride.

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Rx Only

30 Tablets

image

ONCE-DAILY

NDC 58657-711-30

buPROPion Hydrochloride Extended-Release Tablets, USP (XL)

300 mg

WARNING: Do not use in combination with Zyban or any other medicines that contain bupropion hydrochloride.

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Rx Only

30 Tablets

image