Bupropion Hydrochloride

Product NDC
0615-7631
11-digit product format
006157631
Labeler code
0615
Product ID
0615-7631_bbeedc69-56c3-44e2-b594-0c05d1f08942
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA075491
Marketing category
ANDA
Marketing start
2010-02-01
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
75 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 productproduct0615-7631DDiscontinued by firm2026-08-03
excluded packagepackage0615-76310615-7631-39DDiscontinued 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 1 · 38 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 productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-7631-39DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-7631-39DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-7631-39DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-7631-39DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-7631-39DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-7631-39DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-7631-39DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-7631-39DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0615-7631-39DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0615-7631-39DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0615-7631-39DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0615-7631-39DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0615-7631-39IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0615-7631-39IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0615-7631-39IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage0615-7631-39IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0615-7631-39IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0615-7631-39IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0615-7631-39IInactivated by FDA110d247fa046…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…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0615-7631-392022-10-28C16284748780-1960f7f55-d80b-8e05-e053-dbdaa90a074aBupropion Hydrochloride Tabs - Mylan
0615-7631-392019-10-29C16284748780-1960f7f55-d80b-8e05-e053-dbdaa90a074aBupropion Hydrochloride Tabs - Mylan

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KBUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEBUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ABUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
TRIACETININACTIVE INGREDIENTXHX3C3X673BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2

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