Bupropion Hydrochloride

Product NDC
21695-279
11-digit product format
216950279
Labeler code
21695
Product ID
21695-279_22009d23-999c-4fa6-bfe7-21395f577236
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA077715
Marketing category
ANDA
Marketing start
2008-11-26
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 productproduct21695-279IInactivated by FDA2026-08-03
excluded packagepackage21695-27921695-279-30IInactivated by FDA2026-08-03
excluded packagepackage21695-27921695-279-90IInactivated by FDA2026-08-03

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 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 packagepackage21695-279-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-279-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-279-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-279-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-279-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-279-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-279-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-279-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-279-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-279-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-279-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-279-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-279-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-279-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-279-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-279-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-279-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-279-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-279-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-279-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-279-90367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-279-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-279-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-279-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-279-908af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-279-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-279-90834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-279-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-279-901332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-279-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-279-90fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-279-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-279-9086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-279-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-279-90bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-279-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-279-908dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-279-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-279-90e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-279-30e2bbac7714bc…27bdfed8d636…

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…

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
21695-279-30Bupropion HydrochlorideXL30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE301
21695-279-90Bupropion HydrochlorideXL90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-279-30EA - Each21695-2796cc14f04-06ce-40b1-b85d-65a3dea39d6112012-07-24
21695-279-90EA - Each21695-279545dd88d-0ecf-45a3-be69-0eea2388b45d12012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-279BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20100921_22009d23-999c-4fa6-bfe7-21395f577236.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN22009d23-999c-4fa6-bfe7-21395f5772361
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN22009d23-999c-4fa6-bfe7-21395f5772361
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD22009d23-999c-4fa6-bfe7-21395f5772361
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD22009d23-999c-4fa6-bfe7-21395f5772361
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY22009d23-999c-4fa6-bfe7-21395f5772361
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY22009d23-999c-4fa6-bfe7-21395f5772361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-279-302169502793030 in 1 BOTTLE, PLASTICHistorical
21695-279-902169502799090 in 1 BOTTLE, PLASTICHistorical