Bupropion Hydrochloride

Product NDC
63629-3316
11-digit product format
636293316
Labeler code
63629
Product ID
63629-3316_011a5f64-801b-4998-8731-c9c26a2dab67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077715
Marketing category
ANDA
Marketing start
2008-11-26
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
300 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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-3316DDiscontinued by firm2026-08-03
excluded packagepackage63629-331663629-3316-1DDiscontinued by firm2026-08-03
excluded packagepackage63629-331663629-3316-2DDiscontinued by firm2026-08-03
excluded packagepackage63629-331663629-3316-3DDiscontinued by firm2026-08-03
excluded packagepackage63629-331663629-3316-4DDiscontinued by firm2026-08-03
excluded packagepackage63629-331663629-3316-5DDiscontinued by firm2026-08-03
excluded packagepackage63629-331663629-3316-6DDiscontinued by firm2026-08-03

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 3 · 129 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 packagepackage63629-3316-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-3316-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-3316-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-3316-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-3316-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-3316-6d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3316-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3316-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3316-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3316-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3316-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3316-6f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-3316-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-3316-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-3316-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-3316-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-3316-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-3316-62ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-3316-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-3316-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-3316-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-3316-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-3316-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-3316-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-3316-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-3316-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-3316-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-3316-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-3316-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-3316-6cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-3316-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-3316-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-3316-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-3316-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-3316-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-3316-6cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-3316-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-3316-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-3316-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-3316-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-3316-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-3316-6302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-3316-4ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-3316-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-3316-5ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-3316-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-3316-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-3316-6ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-3316-40efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-3316-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-3316-50efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A077715-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26
A077715-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A077715-001AB3

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26782e0a99824c…
2021-12-28 21:50 UTC2021-12A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-13782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077715-001AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077715-001AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077715-001AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077715-001AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077715-001AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077715-001AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077715-001AB312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077715-001AB315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077715-001AB31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077715-001AB31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077715-001AB3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077715-001AB31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077715-001AB311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077715-001AB318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077715-001AB315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077715-001AB315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077715-001AB314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077715-001AB3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077715-001AB31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077715-001AB31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077715-001AB3187673890dc5c…
2021-03-12 10:30 UTC2021-03A077715-001AB315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077715-001AB318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077715-001AB31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077715-001AB313f01610625f2…
2019-09-15 20:21 UTC2019-09A077715-001AB31b00525d2431f…
2019-07-19 19:46 UTC2019-07A077715-001AB31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077715-001AB316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077715-001AB311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077715-001AB31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077715-001AB31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077715-001AB319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077715-001AB31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077715-001AB313f0d92c62455…
2023-05-13 08:27 UTC2023-05A077715-001AB31053a50430f4f…
2023-01-26 05:58 UTC2023-01A077715-001AB313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077715-001AB313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077715-001AB31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077715-001AB31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077715-001AB31cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3316-1EA - Each63629-3316d3865192-7139-4e88-850f-98487e0e865812018-02-20
63629-3316-2EA - Each63629-331638cbc742-cf04-44db-a875-a0c81c5a6c3212018-02-20
63629-3316-3EA - Each63629-33165b809cf5-4f38-46a4-8aba-38b74099c25c12018-02-20
63629-3316-4EA - Each63629-3316498d5bfe-6aa4-4014-ade2-51aa41ae3b9012018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
TALCINACTIVE INGREDIENT7SEV7J4R1UBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEAsclemed USA, Inc.d1d0872c-5b11-4e13-a401-b122348e0fa72026-03-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077715
application number: ANDA077715
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEActavis Pharma, Inc.a1e768fd-c28f-4b49-822d-ccc315b4099c2025-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077715
application number: ANDA077715
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEA-S Medication Solutions9d08b4ae-077d-4cd8-9ca4-8d5cd63f400b2023-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077715
application number: ANDA077715
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEProficient Rx LPec9cbb38-1582-492f-a526-4b3675c55b142023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077715
application number: ANDA077715