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

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	51267-890		I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	51267-890	51267-890-99	I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`

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…`

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
Ingredient	Strength
NALTREXONE HYDROCHLORIDE	90 mg/1
BUPROPION HYDROCHLORIDE	8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Z6375YW9SF	Internal UNII lookup
ZG7E5POY8O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1551468	Internal RxNorm lookup
1551474	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
485ff360-32c8-11df-928b-0002a5d5c51b	Available on FDA.report

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
2e254488-9fcb-41b3-a7c3-e2c9a3941b29	Product name	1	20200603
b4ff0805-126a-406d-9cae-fc34fd8e8889	Product name	1	20190711
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#

Effective, Related label table
Effective	Related label
2023-01-25	These 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
2023-01-25	These 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
2022-07-29	These 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
2022-07-29	These 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 NDC	Product	Description	Form	Quantity	Strength	SPL version
51267-890-07	ContraveExtended-Release	7 in 1 BOTTLE	TABLET, EXTENDED RELEASE	7		27
51267-890-99	ContraveExtended-Release	120 in 1 BOTTLE	TABLET, EXTENDED RELEASE	120		27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51267-890-07	EA - Each	51267-890	da0ac3ff-6207-4556-9305-b8e806ab9f8b	1	2026-04-20
51267-890-99	EA - Each	51267-890	21303583-87d7-4507-a9c2-d916a290fc1a	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51267-890	CONTRAVE EXTENDED-RELEASE (NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NALPROPION PHARMACEUTICALS LLC]	25	Current NDC, Legacy NDC, 2 package rows	20250511_485ff360-32c8-11df-928b-0002a5d5c51b.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 ndc (product): 51267-890

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

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	485ff360-32c8-11df-928b-0002a5d5c51b	27
1551468	naltrexone HCl 8 MG / buPROPion HCl 90 MG 12HR Extended Release Oral Tablet	PSN	485ff360-32c8-11df-928b-0002a5d5c51b	27
1551474	12 HR bupropion hydrochloride 90 MG / naltrexone hydrochloride 8 MG Extended Release Oral Tablet [Contrave]	SBD	485ff360-32c8-11df-928b-0002a5d5c51b	27
1551468	12 HR bupropion hydrochloride 90 MG / naltrexone hydrochloride 8 MG Extended Release Oral Tablet	SCD	485ff360-32c8-11df-928b-0002a5d5c51b	27
1551474	Contrave (bupropion hydrochloride 90 MG / naltrexone hydrochloride 8 MG) 12 HR Extended Release Oral Tablet	SY	485ff360-32c8-11df-928b-0002a5d5c51b	27
1551468	naltrexone HCl 8 MG / buPROPion HCl 90 MG 12HR Extended Release Oral Tablet	SY	485ff360-32c8-11df-928b-0002a5d5c51b	27
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
51267-890-07	51267089007	7 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-07)	2021-01-14		Yes	No	Current
51267-890-99	51267089099	120 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-99)	2014-10-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Contrave Extended-Release	Nalpropion Pharmaceuticals LLC	2025-11-10	HUMAN PRESCRIPTION DRUG LABEL	27
Contrave Extended-Release	PD-Rx Pharmaceuticals, Inc.	2022-05-10	HUMAN PRESCRIPTION DRUG LABEL	20
Contrave Extended-Release	A-S Medication Solutions	2020-01-18	HUMAN PRESCRIPTION DRUG LABEL	13