NDC Code(s) : 51267-890-99, 51267-890-07
Packager : Nalpropion Pharmaceuticals LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Contrave naltrexone hydrochloride and bupropion hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51267-890
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NALTREXONE HYDROCHLORIDE(UNII: Z6375YW9SF)
(NALTREXONE - UNII:5S6W795CQM) 		NALTREXONE HYDROCHLORIDE8 mg
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O)
(BUPROPION - UNII:01ZG3TPX31) 		BUPROPION HYDROCHLORIDE90 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
CYSTEINE HYDROCHLORIDE(UNII: ZT934N0X4W)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
EDETATE DISODIUM(UNII: 7FLD91C86K)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color BLUE Score no score
Shape ROUND (bi-convex) Size 12 mm
Flavor Imprint Code NB;890
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51267-890-99120 in 1 BOTTLE Type 0: Not a Combination Product22/10/2014
2NDC:51267-890-077 in 1 BOTTLE Type 0: Not a Combination Product14/01/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA200063 10/22/2014

LABELER - Nalpropion Pharmaceuticals LLC(081341086)

Establishment
Name Address ID/FEI Business Operations
SpecGx LLC 163205300 API MANUFACTURE(51267-890), ANALYSIS(51267-890)

Establishment
Name Address ID/FEI Business Operations
Cilag AG 483237103 API MANUFACTURE(51267-890), ANALYSIS(51267-890)

Establishment
Name Address ID/FEI Business Operations
Erregierre S.p.A 437721244 API MANUFACTURE(51267-890), ANALYSIS(51267-890)

Establishment
Name Address ID/FEI Business Operations
Chemi S.p.A. 542987644 API MANUFACTURE(51267-890), ANALYSIS(51267-890)

Establishment
Name Address ID/FEI Business Operations
Patheon Inc. (Whitby) 205475333 ANALYSIS(51267-890), MANUFACTURE(51267-890), LABEL(51267-890), PACK(51267-890)

Establishment
Name Address ID/FEI Business Operations
Patheon Inc. (Mississauga) 240769596 ANALYSIS(51267-890)

Establishment
Name Address ID/FEI Business Operations
Erregierre S.p.A. 339722827 API MANUFACTURE(51267-890), ANALYSIS(51267-890)

Establishment
Name Address ID/FEI Business Operations
Micro-Macinazione SA 480918515 ANALYSIS(51267-890), PARTICLE SIZE REDUCTION(51267-890)

Establishment
Name Address ID/FEI Business Operations
Dipharma Francis S.r.l. 446517344 API MANUFACTURE(51267-890), ANALYSIS(51267-890)

Establishment
Name Address ID/FEI Business Operations
Siegfried PharmaChemikalien Minden GmbH 328153106 API MANUFACTURE(51267-890), ANALYSIS(51267-890)

PRINCIPAL DISPLAY PANEL

NDC 51267-890-99

120 tablets

Contrave®
(naltrexone HCl/bupropion HCl)
Extended-Release Tablets

8 mg/90 mg

Attention: Dispense with the
attached Medication Guide

Tablets should not be cut, chewed,
or crushed.

Currax™
pharmaceuticals LLC

Rx only

PRINCIPAL DISPLAY PANEL - 8 mg/90 mg Tablet Bottle Label