WELLBUTRIN SR

Product NDC
61919-036
11-digit product format
619190036
Labeler code
61919
Product ID
61919-036_339b5567-b328-5890-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HCL ER (SR)
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078866
Marketing category
ANDA
Marketing start
2016-05-03
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
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-036UExcluded because listing certification expired2026-08-03
excluded packagepackage61919-03661919-036-60UExcluded because listing certification expired2026-08-03

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 1 · 44 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 productproductUExcluded because listing certification expiredd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-036-60UExcluded because listing certification expiredd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductUExcluded because listing certification expiredf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-036-60UExcluded because listing certification expiredf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductUExcluded because listing certification expired2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-036-60UExcluded because listing certification expired2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductUExcluded because listing certification expireda1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-036-60UExcluded because listing certification expireda1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductUExcluded because listing certification expiredcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-036-60UExcluded because listing certification expiredcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductUExcluded because listing certification expiredcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-036-60UExcluded because listing certification expiredcdf11ea48f46…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 packagepackage61919-036-60UExcluded 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 packagepackage61919-036-60UExcluded 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 packagepackage61919-036-60UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductUExcluded because listing certification expiredad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-036-60UExcluded because listing certification expiredad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductUExcluded because listing certification expired367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-036-60UExcluded because listing certification expired367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductUExcluded because listing certification expired557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-036-60UExcluded because listing certification expired557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductUExcluded because listing certification expired8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-036-60UExcluded because listing certification expired8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductUExcluded because listing certification expired834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-036-60UExcluded because listing certification expired834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductUExcluded because listing certification expired1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-036-60UExcluded because listing certification expired1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductUExcluded because listing certification expiredfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61919-036-60UExcluded because listing certification expiredfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductUExcluded because listing certification expired86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61919-036-60UExcluded because listing certification expired86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductUExcluded because listing certification expiredbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61919-036-60UExcluded because listing certification expiredbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductUExcluded because listing certification expired8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage61919-036-60UExcluded because listing certification expired8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductEExcluded after deficient or non-compliant submission was not correctede2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage61919-036-60EExcluded after deficient or non-compliant submission was not correctede2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductEExcluded after deficient or non-compliant submission was not corrected9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage61919-036-60EExcluded after deficient or non-compliant submission was not corrected9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61919-036-60EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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

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
A078866-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-06
A078866-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-06
A078866-003BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-06

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12010-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12010-04-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-068072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078866-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078866-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078866-002AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078866-003AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078866-001AB115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078866-002AB115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078866-003AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078866-001AB115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078866-002AB115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078866-003AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078866-001AB114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078866-002AB114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078866-003AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078866-001AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078866-002AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078866-003AB1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078866-001AB11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078866-002AB11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078866-003AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078866-001AB11782e0a99824c…
2021-12-28 21:50 UTC2021-12A078866-002AB11782e0a99824c…
2021-12-28 21:50 UTC2021-12A078866-003AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078866-001AB1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078866-002AB1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078866-003AB1187673890dc5c…
2021-03-12 10:30 UTC2021-03A078866-001AB115aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A078866-002AB115aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A078866-003AB115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078866-001AB118869cabd3fbd…
2020-12-22 03:56 UTC2020-12A078866-002AB118869cabd3fbd…
2020-12-22 03:56 UTC2020-12A078866-003AB118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078866-001AB11c0c555d07b60…
2020-11-12 02:37 UTC2020-11A078866-002AB11c0c555d07b60…
2020-11-12 02:37 UTC2020-11A078866-003AB11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078866-001AB113f01610625f2…
2019-12-14 00:12 UTC2019-12A078866-002AB113f01610625f2…
2019-12-14 00:12 UTC2019-12A078866-003AB113f01610625f2…
2019-09-15 20:21 UTC2019-09A078866-001AB11b00525d2431f…
2019-09-15 20:21 UTC2019-09A078866-002AB11b00525d2431f…
2019-09-15 20:21 UTC2019-09A078866-003AB11b00525d2431f…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-036-60WELLBUTRIN SR60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-036-60EA - Each61919-0363f630164-8cf3-4f47-84e5-ce4c73dcaa7212016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-036WELLBUTRIN SR (BUPROPION HCL ER (SR)) TABLET [DIRECT RX]1Legacy NDC, 1 package rows20160525_339b5567-b327-5890-e054-00144ff88e88.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 hydrochlorideBUPROPION HYDROCHLORIDESun Pharmaceutical Industries, Inc.29848192-7de3-4c0d-a822-1268dcf128b02024-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078866
application number: ANDA078866
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEProficient Rx LPd4272e3f-78ee-4d80-b911-e840fb14acbe2019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078866
application number: ANDA078866

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN339b5567-b327-5890-e054-00144ff88e881
993511Wellbutrin SR 100 MG 12HR Extended Release Oral TabletPSN339b5567-b327-5890-e054-00144ff88e881
99351112 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet [Wellbutrin]SBD339b5567-b327-5890-e054-00144ff88e881
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD339b5567-b327-5890-e054-00144ff88e881
99351112 HR Wellbutrin 100 MG Extended Release Oral TabletSY339b5567-b327-5890-e054-00144ff88e881
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY339b5567-b327-5890-e054-00144ff88e881
993511Wellbutrin SR 100 MG 12 HR Extended Release Oral TabletSY339b5567-b327-5890-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-036-606191900366060 in 1 BOTTLEHistorical