BUPROPION HYDROCHLORIDE (SR)

Product NDC
45865-633
11-digit product format
458650633
Labeler code
45865
Product ID
45865-633_72061450-5715-acb4-e053-2a95a90a0a99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA206674
Marketing category
ANDA
Marketing start
2016-07-25
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
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
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct45865-633IInactivated by FDA2026-09-14
excluded packagepackage45865-63345865-633-30IInactivated by FDA2026-09-14

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45865-633-30IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45865-633-30IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45865-633-30IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45865-633-30IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45865-633-30IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45865-633-30IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45865-633-30UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45865-633-30UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45865-633-30UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206674-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2016-02-09
A206674-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-02-09
A206674-003BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2016-02-09

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206674-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2016-02-0984e616aacf4f…
2026-09-14 22:38:342026-08A206674-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-02-0984e616aacf4f…
2026-09-14 22:38:342026-08A206674-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2016-02-0984e616aacf4f…
2026-08-18 06:07:402026-07A206674-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2016-02-09caaa826d4ba7…
2026-08-18 06:07:402026-07A206674-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-02-09caaa826d4ba7…
2026-08-18 06:07:402026-07A206674-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2016-02-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206674-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2016-02-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206674-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-02-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206674-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2016-02-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206674-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2016-02-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206674-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-02-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206674-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2016-02-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A206674-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2016-02-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206674-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-02-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206674-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2016-02-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206674-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2016-02-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206674-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-02-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206674-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2016-02-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206674-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2016-02-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206674-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-02-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206674-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2016-02-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206674-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2016-02-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206674-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-02-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206674-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2016-02-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206674-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2016-02-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206674-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-02-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206674-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2016-02-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206674-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2016-02-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206674-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-02-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206674-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2016-02-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206674-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2016-02-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206674-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-02-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206674-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2016-02-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206674-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2016-02-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A206674-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-02-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A206674-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2016-02-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206674-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2016-02-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206674-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-02-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206674-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2016-02-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206674-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2016-02-09301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206674-001AB115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206674-002AB115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206674-003AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206674-001AB115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206674-002AB115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206674-003AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206674-001AB114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206674-002AB114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206674-003AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206674-001AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206674-002AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206674-003AB1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206674-001AB11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206674-002AB11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206674-003AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206674-001AB11782e0a99824c…
2021-12-28 21:50 UTC2021-12A206674-002AB11782e0a99824c…
2021-12-28 21:50 UTC2021-12A206674-003AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206674-001AB1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206674-002AB1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206674-003AB1187673890dc5c…
2021-03-12 10:30 UTC2021-03A206674-001AB115aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A206674-002AB115aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A206674-003AB115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206674-001AB118869cabd3fbd…
2020-12-22 03:56 UTC2020-12A206674-002AB118869cabd3fbd…
2020-12-22 03:56 UTC2020-12A206674-003AB118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206674-001AB11c0c555d07b60…
2020-11-12 02:37 UTC2020-11A206674-002AB11c0c555d07b60…
2020-11-12 02:37 UTC2020-11A206674-003AB11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206674-001AB113f01610625f2…
2019-12-14 00:12 UTC2019-12A206674-002AB113f01610625f2…
2019-12-14 00:12 UTC2019-12A206674-003AB113f01610625f2…
2019-09-15 20:21 UTC2019-09A206674-001AB11b00525d2431f…
2019-09-15 20:21 UTC2019-09A206674-002AB11b00525d2431f…
2019-09-15 20:21 UTC2019-09A206674-003AB11b00525d2431f…
2019-07-19 19:46 UTC2019-07A206674-001AB11ea99ee380514…
2019-07-19 19:46 UTC2019-07A206674-002AB11ea99ee380514…
2019-07-19 19:46 UTC2019-07A206674-003AB11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206674-001AB116a51e52b5d6a…

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 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
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-633-30BUPROPION HYDROCHLORIDE (SR)30 in 1 BOTTLETABLET, EXTENDED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-633BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20180728_72061450-5714-acb4-e053-2a95a90a0a99.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUPROPION HYDROCHLORIDE SRBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f5d774dd-0f51-4a4f-a9d1-8b5f2364b1f72025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206674
application number: ANDA206674
BUPROPION HYDROCHLORIDE (SR)BUPROPION HYDROCHLORIDECipla USA Inc.,9d2c209b-248e-4e26-9cde-fe0abe4428c12018-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206674
application number: ANDA206674

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN72061450-5714-acb4-e053-2a95a90a0a991
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD72061450-5714-acb4-e053-2a95a90a0a991
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY72061450-5714-acb4-e053-2a95a90a0a991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-633-304586506333030 TABLET, EXTENDED RELEASE in 1 BOTTLE (45865-633-30) 2018-01-010000-00-00NoNoCurrent