Bupropion Hydrochloride

Product NDC
67046-081
Requested package NDC
67046-081-30
11-digit product format
670460081
Labeler code
67046
Product ID
67046-081_597a1ea2-7f77-1d9a-e053-2991aa0a94b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA206556
Marketing category
ANDA
Marketing start
2016-08-29
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
150 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67046-08167046-081-30IInactivated by FDA2026-10-05

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206556-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-26
A206556-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-26

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-2684e616aacf4f…
2026-09-14 22:38:342026-08A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-2684e616aacf4f…
2026-08-18 06:07:402026-07A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-26caaa826d4ba7…
2026-08-18 06:07:402026-07A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32016-08-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32016-08-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32016-08-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32016-08-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32016-08-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32016-08-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32016-08-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32016-08-2674a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206556-001AB315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206556-002AB315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206556-001AB315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206556-002AB315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206556-001AB314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206556-002AB314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206556-001AB3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206556-002AB3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206556-001AB31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206556-002AB31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206556-001AB31782e0a99824c…
2021-12-28 21:50 UTC2021-12A206556-002AB31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206556-001AB3187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206556-002AB3187673890dc5c…
2021-03-12 10:30 UTC2021-03A206556-001AB315aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A206556-002AB315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206556-001AB318869cabd3fbd…
2020-12-22 03:56 UTC2020-12A206556-002AB318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206556-001AB31c0c555d07b60…
2020-11-12 02:37 UTC2020-11A206556-002AB31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206556-001AB313f01610625f2…
2019-12-14 00:12 UTC2019-12A206556-002AB313f01610625f2…
2019-09-15 20:21 UTC2019-09A206556-001AB31b00525d2431f…
2019-09-15 20:21 UTC2019-09A206556-002AB31b00525d2431f…
2019-07-19 19:46 UTC2019-07A206556-001AB31ea99ee380514…
2019-07-19 19:46 UTC2019-07A206556-002AB31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206556-001AB316a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206556-002AB316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206556-001AB311c564ffb4f44…
2024-02-18 07:12 UTC2024-02A206556-002AB311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206556-001AB31ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A206556-002AB31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206556-001AB31a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206556-002AB31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206556-001AB319b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206556-002AB319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206556-001AB31a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206556-002AB31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206556-001AB313f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206556-002AB313f0d92c62455…

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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
67046-081-30Bupropion Hydrochloride(XL)30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-081BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20170918_597a29c0-b1b2-497b-e053-2a91aa0ad2ba.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEProficient Rx LP80f4a4ef-8190-458d-af2e-5daaf32abc012023-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206556
application number: ANDA206556
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEExelan Pharmaceuticals Inc.8a0781c0-e7d5-498e-b7d3-d6bd457f175f2023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206556
application number: ANDA206556
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDECIPLA USA INC.,c2cf79d7-1aba-4391-980b-5e218781f7c62020-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206556
application number: ANDA206556

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN597a29c0-b1b2-497b-e053-2a91aa0ad2ba1
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD597a29c0-b1b2-497b-e053-2a91aa0ad2ba1
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY597a29c0-b1b2-497b-e053-2a91aa0ad2ba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-081-306704600813030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-081-30) 2017-09-180000-00-00NoNoCurrent