Home NDC 43063-772 Contrave
Product NDC 43063-772
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 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43063-772-70 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43063-772-70 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 43063-772-70 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 43063-772-70 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 43063-772-70 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 43063-772-70 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 43063-772-70 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 43063-772-70 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 43063-772-70 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 43063-772-70 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 43063-772-70 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 43063-772-70 557ba5c1ecfa…9c80585c8c6e…
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.
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 Product TE source text 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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