NDC Code(s) : 63739-132-33
Packager : McKesson Corporation DBA SKY Packaging

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:63739-132(NDC:24979-102)
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
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
ETHYLCELLULOSE (100 MPA.S)(UNII: 47MLB0F1MV)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
Product Characteristics
Color white (White) Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code T102
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63739-132-333 in 1 BOX, UNIT-DOSE 09/12/2023
110 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210081 09/12/2023

LABELER - McKesson Corporation DBA SKY Packaging(140529962)

Establishment
Name Address ID/FEI Business Operations
Legacy Pharmaceutical Packaging 143213275 repack(63739-132), relabel(63739-132)

PRINCIPAL DISPLAY PANEL


Bupropion Hydrochloride Extended-Release Tablets (XL), USP, 300 mg

PRINCIPAL DISPLAY PANEL