Bupropion Hydrochloride

Product NDC
66336-897
11-digit product format
663360897
Labeler code
66336
Product ID
66336-897_05293257-1c22-45f7-8c6a-204043bab144
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET
Route
OCCLUSIVE DRESSING TECHNIQUE
Labeler
Dispensing Solutions, Inc.
Application
ANDA077455
Marketing category
ANDA
Marketing start
2008-03-12
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
E
Listing certified through
2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66336-897IInactivated by FDA2026-10-05
excluded packagepackage66336-89766336-897-30IInactivated by FDA2026-10-05
excluded packagepackage66336-89766336-897-60IInactivated 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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66336-897-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66336-897-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-897-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-897-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-897-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-897-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-897-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-897-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-897-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-897-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-897-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-897-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66336-897-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66336-897-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66336-897-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66336-897-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66336-897-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66336-897-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66336-897-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66336-897-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66336-897-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66336-897-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66336-897-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66336-897-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66336-897-608af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66336-897-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66336-897-60834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66336-897-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66336-897-601332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66336-897-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage66336-897-60fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage66336-897-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage66336-897-6086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage66336-897-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage66336-897-60bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage66336-897-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66336-897-608dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66336-897-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66336-897-60e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66336-897-30e2bbac7714bc…27bdfed8d636…

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
A077455-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-19
A077455-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-12
A077455-003BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-19

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 22:38:342026-08A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-1284e616aacf4f…
2026-09-14 22:38:342026-08A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-1984e616aacf4f…
2026-08-18 06:07:402026-07A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-12caaa826d4ba7…
2026-08-18 06:07:402026-07A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-19301d65b070ca…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A077455-001AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077455-002AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077455-003AB1174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A077455-001AB113f01610625f2…
2019-12-14 00:12 UTC2019-12A077455-002AB113f01610625f2…
2019-12-14 00:12 UTC2019-12A077455-003AB113f01610625f2…
2019-09-15 20:21 UTC2019-09A077455-001AB11b00525d2431f…
2019-09-15 20:21 UTC2019-09A077455-002AB11b00525d2431f…
2019-09-15 20:21 UTC2019-09A077455-003AB11b00525d2431f…
2019-07-19 19:46 UTC2019-07A077455-001AB11ea99ee380514…
2019-07-19 19:46 UTC2019-07A077455-002AB11ea99ee380514…
2019-07-19 19:46 UTC2019-07A077455-003AB11ea99ee380514…

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
66336-897-30Bupropion Hydrochloride30 in 1 BOTTLETABLET301
66336-897-60Bupropion Hydrochloride60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66336-897-30EA - Each66336-897c92da8d5-6338-40c6-b0d9-d9471a5aaa0312012-07-24
66336-897-60EA - Each66336-897d34b897b-e4bf-49ba-b9b5-5ea34d3eb97612012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-897BUPROPION HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 2 package rows20110923_c111fe19-3419-461c-83c9-6d809d6ac6bb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-897-306633608973030 in 1 BOTTLEHistorical
66336-897-606633608976060 in 1 BOTTLEHistorical