Bupropion Hydrochloride

Product NDC
53808-0910
11-digit product format
538080910
Labeler code
53808
Product ID
53808-0910_b5efba99-807d-4778-b769-e95c960a9e86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA075491
Marketing category
ANDA
Marketing start
2009-07-01
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 productproduct53808-0910IInactivated by FDA2026-08-03
excluded packagepackage53808-091053808-0910-1IInactivated 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 1 · 44 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 packagepackage53808-0910-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53808-0910-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53808-0910-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53808-0910-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53808-0910-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53808-0910-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53808-0910-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53808-0910-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53808-0910-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53808-0910-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53808-0910-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53808-0910-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53808-0910-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53808-0910-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53808-0910-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53808-0910-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53808-0910-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53808-0910-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53808-0910-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53808-0910-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53808-0910-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53808-0910-1110d247fa046…a55b01930146…

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
A075491-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-04-17
A075491-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-04-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075491-001AB
A075491-002AB

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 UTC2026-02A075491-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075491-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075491-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075491-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A075491-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075491-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075491-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075491-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075491-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075491-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075491-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-04-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075491-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075491-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-04-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075491-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075491-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-04-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075491-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075491-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-04-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075491-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075491-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-04-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A075491-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-04-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075491-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-04-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075491-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-04-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075491-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-04-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075491-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-04-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075491-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-04-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075491-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-04-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075491-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-04-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075491-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-04-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075491-001BUPROPION HYDROCHLORIDE75MGTABLET / ORAL2000-04-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075491-002BUPROPION HYDROCHLORIDE100MGTABLET / ORAL2000-04-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075491-001BUPROPION HYDROCHLORIDE75MGTABLET / ORAL2000-04-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075491-002BUPROPION HYDROCHLORIDE100MGTABLET / ORAL2000-04-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075491-001BUPROPION HYDROCHLORIDE75MGTABLET / ORAL2000-04-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075491-002BUPROPION HYDROCHLORIDE100MGTABLET / ORAL2000-04-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075491-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-04-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075491-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-04-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075491-001BUPROPION HYDROCHLORIDE75MGTABLET / ORAL2000-04-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075491-002BUPROPION HYDROCHLORIDE100MGTABLET / ORAL2000-04-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075491-001BUPROPION HYDROCHLORIDE75MGTABLET / ORAL2000-04-17782e0a99824c…
2021-12-28 21:50 UTC2021-12A075491-002BUPROPION HYDROCHLORIDE100MGTABLET / ORAL2000-04-17782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075491-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075491-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075491-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075491-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075491-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075491-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075491-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075491-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075491-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075491-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075491-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075491-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075491-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075491-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075491-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075491-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075491-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075491-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075491-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075491-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075491-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075491-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075491-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075491-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075491-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075491-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075491-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075491-002AB18072bd15b7f6…
2019-12-13 00:20 UTC2019-12A075491-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075491-002AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075491-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075491-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075491-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A075491-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075491-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A075491-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075491-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A075491-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075491-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A075491-002AB13f01610625f2…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0910-12019-10-21C16284748780-1956f9ecf-cd8f-621f-e053-dbdaa90a74ad8e9b33e3-beb8-4970-bba5-78fbde261ce5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0910-1Bupropion Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOBUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEBUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ABUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0910BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100805_8e9b33e3-beb8-4970-bba5-78fbde261ce5.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs4fbe64aa-f8f4-45fa-88ae-e844997703ae2026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075491
application number: ANDA075491
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEA-S Medication Solutionsd86e26e0-6e10-4d59-8cc8-94b551774b862026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075491
application number: ANDA075491
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDECoupler LLC47b96919-a8ea-b769-e063-6394a90aa34e2026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075491
application number: ANDA075491
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEAurobindo Pharma Limited6563b923-269f-40c3-b992-cbacdfca6e162025-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075491
application number: ANDA075491
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEBryant Ranch Prepack9a3b97be-afa3-49e6-962f-662b6807e6072025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075491
application number: ANDA075491

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993687buPROPion HCl 100 MG Oral TabletPSN8e9b33e3-beb8-4970-bba5-78fbde261ce51
993691buPROPion HCl 75 MG Oral TabletPSN8e9b33e3-beb8-4970-bba5-78fbde261ce51
993687bupropion hydrochloride 100 MG Oral TabletSCD8e9b33e3-beb8-4970-bba5-78fbde261ce51
993691bupropion hydrochloride 75 MG Oral TabletSCD8e9b33e3-beb8-4970-bba5-78fbde261ce51
993691bupropion HCl 75 MG Oral TabletSY8e9b33e3-beb8-4970-bba5-78fbde261ce51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0910-15380809100130 in 1 BLISTER PACKHistorical