bupropion

Product NDC
68001-264
Requested package NDC
68001-264-04
11-digit product format
680010264
Labeler code
68001
Product ID
68001-264_688cfb04-0f6b-4e42-be01-b0e4c33b1402
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA201567
Marketing category
ANDA
Marketing start
2014-10-03
Marketing end
0000-00-00
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
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68001-26468001-264-04DDiscontinued 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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
A201567-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-17
A201567-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201567-001AB3
A201567-002AB3

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 UTC2026-02A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201567-001BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32014-01-17782e0a99824c…
2021-12-28 21:50 UTC2021-12A201567-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-07-23782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A201567-001AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201567-002AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201567-001AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201567-002AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201567-001AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201567-002AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201567-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201567-002AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201567-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201567-002AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201567-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201567-002AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201567-001AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201567-002AB312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201567-001AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201567-002AB315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201567-001AB31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201567-002AB31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201567-001AB31d06236e962d9…
2024-10-29 15:01 UTC2024-10A201567-002AB31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201567-001AB3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201567-002AB3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201567-001AB31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201567-002AB31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201567-001AB311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201567-002AB311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201567-001AB318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201567-002AB318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201567-001AB315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201567-002AB315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201567-001AB315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201567-002AB315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201567-001AB314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201567-002AB314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201567-001AB3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201567-002AB3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201567-001AB31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201567-002AB31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201567-001AB31782e0a99824c…
2021-12-28 21:50 UTC2021-12A201567-002AB31782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-264-03EA - Each68001-2643c513204-a5da-4cf9-b684-2a144800e07e12014-12-01
68001-264-04EA - Each68001-26401f61c33-27fd-4344-92c4-10fb240e1e4c12014-12-01
68001-264-05EA - Each68001-264a6d244d2-c83f-42b9-9c1f-6385bcdcea1112014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XBUPROPION TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3BUPROPION TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BBUPROPION TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BUPROPION TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBUPROPION TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BUPROPION TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656BUPROPION TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABUPROPION TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EBUPROPION TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BUPROPION TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
SHELLACINACTIVE INGREDIENT46N107B71OBUPROPION TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUPROPION TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bupropionBUPROPIONZydus Lifesciences Limited78d34aad-9d4f-48c4-91eb-536e31c6b6c92024-11-26Exact identifier
application applno (ANDA): 201567
application number: ANDA201567
bupropionBUPROPIONZydus Pharmaceuticals USA Inc.8d937ca3-3351-40f1-8192-348ba0c681622024-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201567
application number: ANDA201567
bupropionBUPROPIONProficient Rx LP47ceb7e1-b2f7-47f8-8b6a-85eea36606b82021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201567
application number: ANDA201567

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-264-046800102640430 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-264-04) 2014-10-030000-00-00NoNoCurrent