Contrave

Product NDC: 50090-2945
Requested package NDC: 50090-2945-0
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-2945	50090-2945-0	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N200063-001	CONTRAVE	BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2014-09-10

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N200063-001	9107837	2027-06-04	U-1639		2015-09-03
N200063-001	10307376	2027-11-08	U-1585		2019-06-17
N200063-001	12048769	2027-11-08	U-1585		2024-08-19
N200063-001	8318788	2027-11-08	U-1584		2014-10-06
N200063-001	8722085	2027-11-08	U-1585		2014-10-06
N200063-001	9125868	2027-11-08	U-1585		2015-10-15
N200063-001	8088786	2029-02-03		Drug product	2014-10-06
N200063-001	11324741	2029-05-29	U-1583		2022-05-19
N200063-001	8916195	2030-02-02	U-1639		2015-01-20
N200063-001	11033543	2031-01-10	U-1583		2021-09-22
N200063-001	9248123	2032-01-13	U-1808		2016-02-17
N200063-001	10403170	2033-06-05	U-1583		2021-10-29
N200063-001	11139056	2033-06-05	U-1583		2021-10-29
N200063-001	9633575	2033-06-25	U-1583		2021-10-29
N200063-001	10231964	2034-07-02	U-1583		2019-04-17
N200063-001	10828294	2034-07-02	U-1583		2020-12-14
N200063-001	10835527	2034-07-02	U-1583		2020-12-14
N200063-001	11998542	2034-07-02	U-1583		2024-07-05

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 20 · 793 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N200063-001	9107837	2027-06-04	U-1639		2015-09-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200063-001	10307376	2027-11-08	U-1585		2019-06-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200063-001	12048769	2027-11-08	U-1585		2024-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200063-001	8318788	2027-11-08	U-1584		2014-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200063-001	8722085	2027-11-08	U-1585		2014-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200063-001	9125868	2027-11-08	U-1585		2015-10-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200063-001	8088786	2029-02-03		Drug product	2014-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200063-001	11324741	2029-05-29	U-1583		2022-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200063-001	8916195	2030-02-02	U-1639		2015-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200063-001	11033543	2031-01-10	U-1583		2021-09-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200063-001	9248123	2032-01-13	U-1808		2016-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200063-001	10403170	2033-06-05	U-1583		2021-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200063-001	11139056	2033-06-05	U-1583		2021-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200063-001	9633575	2033-06-25	U-1583		2021-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200063-001	10231964	2034-07-02	U-1583		2019-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200063-001	10828294	2034-07-02	U-1583		2020-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200063-001	10835527	2034-07-02	U-1583		2020-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200063-001	11998542	2034-07-02	U-1583		2024-07-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N200063-001	9107837	2027-06-04	U-1639		2015-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	10307376	2027-11-08	U-1585		2019-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	12048769	2027-11-08	U-1585		2024-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	8318788	2027-11-08	U-1584		2014-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	8722085	2027-11-08	U-1585		2014-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	9125868	2027-11-08	U-1585		2015-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	8088786	2029-02-03		Drug product	2014-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	11324741	2029-05-29	U-1583		2022-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	8916195	2030-02-02	U-1639		2015-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	11033543	2031-01-10	U-1583		2021-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	9248123	2032-01-13	U-1808		2016-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	10403170	2033-06-05	U-1583		2021-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	11139056	2033-06-05	U-1583		2021-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	9633575	2033-06-25	U-1583		2021-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	10231964	2034-07-02	U-1583		2019-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	10828294	2034-07-02	U-1583		2020-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	10835527	2034-07-02	U-1583		2020-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	11998542	2034-07-02	U-1583		2024-07-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200063-001	9107837	2027-06-04	U-1639		2015-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	10307376	2027-11-08	U-1585		2019-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	12048769	2027-11-08	U-1585		2024-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	8318788	2027-11-08	U-1584		2014-10-06	`011fe1cb6892…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4eceb285-f3c7-4092-a21a-4c9f3169f20c	Product name	5	20260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8	Product name	3	20240209
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
b8ee525f-67fb-39fb-91da-7e47ac54581d	Product name	5	20200611
98e65af1-f5d0-75d5-c930-f8a4ce4c3284	Product name	9	20190211
31849934-38d8-47fe-b84a-4d392838c14b	Product name	1	20170823
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778	Product name	1	20161103
e4d463bc-c674-43cb-be06-82786f310d01	Product name	1	20150326
0916dcfb-331f-89b1-8eac-6f7dc76d82da	Product name	1	20140508
7a537f54-d322-5e54-a3a2-035d3e21c3c6	Product name	1	20140508
d7fc3d53-5a6c-de82-2808-1780f175f17e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-2945-0	2023-01-30	C162847	48780-1	f386c64a-28b5-0266-e053-dadaa90a7c1a	These 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 NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-2945-0	ContraveExtended-Release	120 in 1 BOTTLE	TABLET, EXTENDED RELEASE	120		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-2945-0	EA - Each	50090-2945	dcb86c3c-6738-44fa-8419-a1c9871d33b4	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-2945	CONTRAVE EXTENDED-RELEASE (NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]	13	Legacy NDC, 1 package rows	20200122_9889a75d-4197-496c-aae1-15c9058c1d1b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Contrave Extended-Release	NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE	Nalpropion Pharmaceuticals LLC	485ff360-32c8-11df-928b-0002a5d5c51b	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 200063 application number: NDA200063

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Z6375YW9SF	NALTREXONE HYDROCHLORIDE	16676-29-2	NALTREXONE HYDROCHLORIDE
ZG7E5POY8O	BUPROPION HYDROCHLORIDE	31677-93-7	BUPROPION HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1551474	Contrave 8 MG / 90 MG 12HR Extended Release Oral Tablet	PSN	9889a75d-4197-496c-aae1-15c9058c1d1b	13
1551468	naltrexone HCl 8 MG / buPROPion HCl 90 MG 12HR Extended Release Oral Tablet	PSN	9889a75d-4197-496c-aae1-15c9058c1d1b	13
1551474	12 HR bupropion hydrochloride 90 MG / naltrexone hydrochloride 8 MG Extended Release Oral Tablet [Contrave]	SBD	9889a75d-4197-496c-aae1-15c9058c1d1b	13
1551468	12 HR bupropion hydrochloride 90 MG / naltrexone hydrochloride 8 MG Extended Release Oral Tablet	SCD	9889a75d-4197-496c-aae1-15c9058c1d1b	13
1551474	Contrave (bupropion hydrochloride 90 MG / naltrexone hydrochloride 8 MG) 12 HR Extended Release Oral Tablet	SY	9889a75d-4197-496c-aae1-15c9058c1d1b	13
1551468	naltrexone HCl 8 MG / buPROPion HCl 90 MG 12HR Extended Release Oral Tablet	SY	9889a75d-4197-496c-aae1-15c9058c1d1b	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-2945-0	50090294500	120 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-2945-0)	2017-03-30	0000-00-00	No	No	Current