Bupropion Hydrochloride

Product NDC
0615-7915
11-digit product format
006157915
Labeler code
0615
Product ID
0615-7915_986d7395-1848-4336-ad31-66ba3045ed99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA077284
Marketing category
ANDA
Marketing start
2007-06-12
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0615-7915DDiscontinued by firm2026-08-17
excluded packagepackage0615-79150615-7915-39DDiscontinued by firm2026-08-17

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 · 30 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 packagepackage0615-7915-39DDiscontinued 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 packagepackage0615-7915-39DDiscontinued 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 packagepackage0615-7915-39DDiscontinued 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 packagepackage0615-7915-39DDiscontinued 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 packagepackage0615-7915-39DDiscontinued 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 packagepackage0615-7915-39DDiscontinued 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 packagepackage0615-7915-39DDiscontinued 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 packagepackage0615-7915-39DDiscontinued 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 packagepackage0615-7915-39DDiscontinued 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 packagepackage0615-7915-39DDiscontinued 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 packagepackage0615-7915-39DDiscontinued 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 packagepackage0615-7915-39DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0615-7915-39IInactivated 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 packagepackage0615-7915-39IInactivated by FDA9bebd1f3094a…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 packagepackage0615-7915-39EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077284-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2006-12-14
A077284-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2006-12-14

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077284-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2006-12-14caaa826d4ba7…
2026-08-18 06:07:402026-07A077284-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2006-12-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077284-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2006-12-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077284-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2006-12-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077284-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2006-12-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077284-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2006-12-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A077284-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2006-12-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077284-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2006-12-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077284-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2006-12-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077284-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2006-12-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077284-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2006-12-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077284-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2006-12-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077284-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2006-12-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077284-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2006-12-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077284-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2006-12-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077284-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2006-12-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077284-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2006-12-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077284-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2006-12-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077284-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2006-12-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077284-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2006-12-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077284-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2006-12-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A077284-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2006-12-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077284-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2006-12-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077284-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2006-12-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077284-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2006-12-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077284-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2006-12-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077284-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2006-12-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077284-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2006-12-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077284-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2006-12-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077284-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2006-12-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077284-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32006-12-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077284-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32006-12-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077284-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32006-12-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077284-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32006-12-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077284-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32006-12-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077284-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32006-12-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077284-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32006-12-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077284-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32006-12-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077284-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32006-12-14bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077284-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32006-12-14bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077284-001AB315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077284-002AB315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077284-001AB315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077284-002AB315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077284-001AB314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077284-002AB314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077284-001AB3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077284-002AB3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077284-001AB31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077284-002AB31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077284-001AB31782e0a99824c…
2021-12-28 21:50 UTC2021-12A077284-002AB31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077284-001AB3187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077284-002AB3187673890dc5c…
2021-03-12 10:30 UTC2021-03A077284-001AB315aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077284-002AB315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077284-001AB318869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077284-002AB318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077284-001AB31c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077284-002AB31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077284-001AB313f01610625f2…
2019-12-14 00:12 UTC2019-12A077284-002AB313f01610625f2…
2019-09-15 20:21 UTC2019-09A077284-001AB31b00525d2431f…
2019-09-15 20:21 UTC2019-09A077284-002AB31b00525d2431f…
2019-07-19 19:46 UTC2019-07A077284-001AB31ea99ee380514…
2019-07-19 19:46 UTC2019-07A077284-002AB31ea99ee380514…
2023-12-20 04:57 UTC2023-12A077284-002AB31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077284-002AB31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077284-002AB319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077284-001AB31a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077284-002AB31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077284-001AB313f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077284-002AB313f0d92c62455…
2023-05-13 08:27 UTC2023-05A077284-001AB31053a50430f4f…
2023-05-13 08:27 UTC2023-05A077284-002AB31053a50430f4f…
2023-01-26 05:58 UTC2023-01A077284-001AB313bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A077284-002AB313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077284-001AB313a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077284-002AB313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077284-001AB31f41ea6bd6efb…

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EABUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1