Bupropion Hydrochloride

Product NDC
0378-2009
11-digit product format
003782009
Labeler code
0378
Product ID
0378-2009_116e58a5-3927-4360-b0be-bf08fc47c5d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA090942
Marketing category
ANDA
Marketing start
2010-09-28
Marketing end
2019-11-30
Substance
BUPROPION HYDROCHLORIDE
Active strength
300 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
No
Listing certified through
0000-00-00
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 productproduct0378-2009DDiscontinued by firm2026-08-03
excluded packagepackage0378-20090378-2009-05DDiscontinued 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 · 24 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 packagepackage0378-2009-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0378-2009-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0378-2009-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0378-2009-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0378-2009-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0378-2009-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0378-2009-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0378-2009-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0378-2009-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0378-2009-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0378-2009-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0378-2009-05557ba5c1ecfa…9c80585c8c6e…

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
A090942-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-07-14
A090942-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2010-07-14

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 · 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 UTC2026-02A090942-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-07-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090942-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2010-07-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090942-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-07-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090942-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2010-07-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A090942-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-07-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090942-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2010-07-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090942-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-07-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090942-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2010-07-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090942-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-07-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090942-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2010-07-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090942-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-07-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090942-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2010-07-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090942-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-07-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090942-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2010-07-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090942-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-07-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090942-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2010-07-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090942-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-07-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090942-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2010-07-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090942-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-07-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A090942-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2010-07-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090942-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-07-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090942-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2010-07-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090942-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-07-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090942-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2010-07-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090942-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-07-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090942-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2010-07-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090942-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-07-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090942-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2010-07-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090942-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-07-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090942-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2010-07-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090942-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-07-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090942-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2010-07-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090942-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-07-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090942-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2010-07-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090942-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-07-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090942-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2010-07-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090942-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-07-14bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090942-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2010-07-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090942-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-07-14782e0a99824c…
2021-12-28 21:50 UTC2021-12A090942-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2010-07-14782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A090942-002AB31b00525d2431f…
2019-07-19 19:46 UTC2019-07A090942-001AB31ea99ee380514…
2019-07-19 19:46 UTC2019-07A090942-002AB31ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-2009-05EA - Each0378-2009bb6e1822-44a4-4692-95e1-e5c4c30a353e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]12
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]12
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]12
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]12
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]12
MANNITOLINACTIVE INGREDIENT3OWL53L36ABUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]12
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]12
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]12
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]12
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]12
POVIDONESINACTIVE INGREDIENTFZ989GH94EBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]12
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]12
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]12
TALCINACTIVE INGREDIENT7SEV7J4R1UBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]12
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]12
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
MANNITOLINACTIVE INGREDIENT3OWL53L36ABUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
POVIDONESINACTIVE INGREDIENTFZ989GH94EBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1UBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6