NDC Code(s) : 47781-637-30
Packager : Alvogen Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

bupropion hydrochloridebupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47781-637
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O)
(BUPROPION - UNII:01ZG3TPX31) 		BUPROPION HYDROCHLORIDE450 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
HYDROCHLORIC ACID(UNII: QTT17582CB)
STEARIC ACID(UNII: 4ELV7Z65AP)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
TRIACETIN(UNII: XHX3C3X673)
TALC(UNII: 7SEV7J4R1U)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(UNII: K679OBS311)
POLYETHYLENE OXIDE 2000000(UNII: 5K3991GVWI)
POLYVINYL ACETATE(UNII: 32K497ZK2U)
POVIDONE K30(UNII: U725QWY32X)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code BUP450
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:47781-637-3030 in 1 BOTTLE Type 0: Not a Combination Product28/09/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA022497 09/28/2018 03/01/2026

LABELER - Alvogen Inc.(008057330)

PRINCIPAL DISPLAY PANEL

NDC 47781-637-30

Once Daily
buPROPion Hydrochloride
Extended-release Tablets (XL)

450 mg

Pharmacist: Dispense the accompanying Medication Guide to each patient

WARNING: Do not use with other medicines that contain bupropion hydrochloride or bupropion hydrobromide.

30 Tablets
Rx only