Contrave

Product NDC: 43063-772
Requested package NDC: 43063-772-70
11-digit product format: 430630772
Labeler code: 43063
Product ID: 43063-772_dea9a508-9ae4-9a58-e053-2a95a90a967f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: naltrexone hydrochloride and bupropion hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: NDA200063
Marketing category: NDA
Marketing start: 2014-10-22
Marketing end: 0000-00-00
Substance: BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
Active strength: 90 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: 2023-12-31
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	43063-772	43063-772-70	D	Discontinued by firm		2026-08-17

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 · 12 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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 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…`
2022-09-29 23:25 UTC	2022-09	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 20 · 775 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
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…`
2026-02-19 14:30 UTC	2026-02	N200063-001	8722085	2027-11-08	U-1585		2014-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	9125868	2027-11-08	U-1585		2015-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	8088786	2029-02-03		Drug product	2014-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	11324741	2029-05-29	U-1583		2022-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	8916195	2030-02-02	U-1639		2015-01-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	11033543	2031-01-10	U-1583		2021-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	9248123	2032-01-13	U-1808		2016-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	10403170	2033-06-05	U-1583		2021-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	11139056	2033-06-05	U-1583		2021-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	9633575	2033-06-25	U-1583		2021-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	10231964	2034-07-02	U-1583		2019-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	10828294	2034-07-02	U-1583		2020-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	10835527	2034-07-02	U-1583		2020-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	11998542	2034-07-02	U-1583		2024-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200063-001	7375111	2025-03-26		Drug product	2014-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200063-001	9107837	2027-06-04	U-1639		2015-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200063-001	10307376	2027-11-08	U-1585		2019-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200063-001	12048769	2027-11-08	U-1585		2024-08-19	`31067a03dcf5…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-772-70	EA - Each	43063-772	39e1d5dc-c732-4ca1-82ac-d130b436b6cd	1	2017-07-07

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
ZG7E5POY8O	BUPROPION HYDROCHLORIDE	31677-93-7	BUPROPION HYDROCHLORIDE
Z6375YW9SF	NALTREXONE HYDROCHLORIDE	16676-29-2	NALTREXONE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-772-70	43063077270	70 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-772-70)	2017-06-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Contrave Extended-Release	PD-Rx Pharmaceuticals, Inc.	2022-05-10	HUMAN PRESCRIPTION DRUG LABEL	20