FDA.reportPublic FDA data

Contrave

Product NDC
51267-890
11-digit product format
512670890
Labeler code
51267
Product ID
51267-890_8e7e5582-7a35-4ec7-85e7-b88a98d1bd23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naltrexone hydrochloride and bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Nalpropion Pharmaceuticals LLC
Application
NDA200063
Marketing category
NDA
Marketing start
2014-10-22
Substance
BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
Active strength
90; 8 mg/1; mg/1
Pharmacologic classes
Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Contrave
Brand name suffix
Extended-Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE90 mg/1
NALTREXONE HYDROCHLORIDE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O, Z6375YW9SF
Rxcui1551468, 1551474

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
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
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
51267-890-992023-01-25C16284748780-1e4f33bdf-b28b-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use CONTRAVE ® safely and effectively. See full prescribing information for CONTRAVE. CONTRAVE (naltrexone hydrochloride and bupropion hydrochloride) extended-release tablets, for oral use Initial U.S. Approval: 2014
51267-890-992023-01-25C16284748780-1e4f33bdf-b28b-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use CONTRAVE ® safely and effectively. See full prescribing information for CONTRAVE. CONTRAVE (naltrexone hydrochloride and bupropion hydrochloride) extended-release tablets, for oral use Initial U.S. Approval: 2014
51267-890-992022-07-29C16284748780-1e4f33bdf-b28b-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use CONTRAVE ® safely and effectively. See full prescribing information for CONTRAVE. CONTRAVE (naltrexone hydrochloride and bupropion hydrochloride) extended-release tablets, for oral use Initial U.S. Approval: 2014
51267-890-992022-07-29C16284748780-1e4f33bdf-b28b-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use CONTRAVE ® safely and effectively. See full prescribing information for CONTRAVE. CONTRAVE (naltrexone hydrochloride and bupropion hydrochloride) extended-release tablets, for oral use Initial U.S. Approval: 2014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51267-890-07ContraveExtended-Release7 in 1 BOTTLETABLET, EXTENDED RELEASE727
51267-890-99ContraveExtended-Release120 in 1 BOTTLETABLET, EXTENDED RELEASE12027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51267-890-07EA - Each51267-890da0ac3ff-6207-4556-9305-b8e806ab9f8b12026-04-20
51267-890-99EA - Each51267-89021303583-87d7-4507-a9c2-d916a290fc1a12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51267-890CONTRAVE EXTENDED-RELEASE (NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NALPROPION PHARMACEUTICALS LLC]25Current NDC, Legacy NDC, 2 package rows20250511_485ff360-32c8-11df-928b-0002a5d5c51b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1551474Contrave 8 MG / 90 MG 12HR Extended Release Oral TabletPSN485ff360-32c8-11df-928b-0002a5d5c51b27
1551468naltrexone HCl 8 MG / buPROPion HCl 90 MG 12HR Extended Release Oral TabletPSN485ff360-32c8-11df-928b-0002a5d5c51b27
155147412 HR bupropion hydrochloride 90 MG / naltrexone hydrochloride 8 MG Extended Release Oral Tablet [Contrave]SBD485ff360-32c8-11df-928b-0002a5d5c51b27
155146812 HR bupropion hydrochloride 90 MG / naltrexone hydrochloride 8 MG Extended Release Oral TabletSCD485ff360-32c8-11df-928b-0002a5d5c51b27
1551474Contrave (bupropion hydrochloride 90 MG / naltrexone hydrochloride 8 MG) 12 HR Extended Release Oral TabletSY485ff360-32c8-11df-928b-0002a5d5c51b27
1551468naltrexone HCl 8 MG / buPROPion HCl 90 MG 12HR Extended Release Oral TabletSY485ff360-32c8-11df-928b-0002a5d5c51b27
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
51267-890-07512670890077 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-07) 2021-01-14YesNoHistorical
51267-890-9951267089099120 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-99) 2014-10-220000-00-00NoNoCurrent