FDA.reportPublic FDA data

Contrave

Product NDC
50090-2945
11-digit product format
500902945
Labeler code
50090
Product ID
50090-2945_ca584fad-9f6d-43ce-b08c-11fff7b2e335
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naltrexone hydrochloride and bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA200063
Marketing category
NDA
Marketing start
2014-10-22
Marketing end
0000-00-00
Substance
NALTREXONE HYDROCHLORIDE; BUPROPION HYDROCHLORIDE
Active strength
8 mg/1; mg/1
Pharmacologic classes
Opioid Antagonist [EPC],Opioid Antagonists [MoA],Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
31849934-38d8-47fe-b84a-4d392838c14bProduct name120170823
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778Product name120161103
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
7a537f54-d322-5e54-a3a2-035d3e21c3c6Product name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2945-02023-01-30C16284748780-1f386c64a-28b5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CONTRAVE ® safely and effectively. See full prescribing information for CONTRAVE. CONTRAVE (naltrexone HCl and bupropion HCl) Extended-Release Tablets Initial U.S. Approval: 2014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2945-0ContraveExtended-Release120 in 1 BOTTLETABLET, EXTENDED RELEASE12013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2945-0EA - Each50090-2945dcb86c3c-6738-44fa-8419-a1c9871d33b412019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2945CONTRAVE EXTENDED-RELEASE (NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]13Legacy NDC, 1 package rows20200122_9889a75d-4197-496c-aae1-15c9058c1d1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1551474Contrave 8 MG / 90 MG 12HR Extended Release Oral TabletPSN9889a75d-4197-496c-aae1-15c9058c1d1b13
1551468naltrexone HCl 8 MG / buPROPion HCl 90 MG 12HR Extended Release Oral TabletPSN9889a75d-4197-496c-aae1-15c9058c1d1b13
155147412 HR bupropion hydrochloride 90 MG / naltrexone hydrochloride 8 MG Extended Release Oral Tablet [Contrave]SBD9889a75d-4197-496c-aae1-15c9058c1d1b13
155146812 HR bupropion hydrochloride 90 MG / naltrexone hydrochloride 8 MG Extended Release Oral TabletSCD9889a75d-4197-496c-aae1-15c9058c1d1b13
1551474Contrave (bupropion hydrochloride 90 MG / naltrexone hydrochloride 8 MG) 12 HR Extended Release Oral TabletSY9889a75d-4197-496c-aae1-15c9058c1d1b13
1551468naltrexone HCl 8 MG / buPROPion HCl 90 MG 12HR Extended Release Oral TabletSY9889a75d-4197-496c-aae1-15c9058c1d1b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2945-050090294500120 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-2945-0) 2017-03-300000-00-00NoNoCurrent