Bupropion Hydrochloride

Product NDC
0440-7200
11-digit product format
004407200
Labeler code
0440
Product ID
0440-7200_f8a183f3-d5a0-4d7f-9a81-20f9157db48d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA077455
Marketing category
ANDA
Marketing start
2008-03-12
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
2018-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0440-7200IInactivated by FDA2026-10-05
excluded packagepackage0440-72000440-7200-30IInactivated by FDA2026-10-05
excluded packagepackage0440-72000440-7200-60IInactivated by FDA2026-10-05
excluded packagepackage0440-72000440-7200-81IInactivated by FDA2026-10-05
excluded packagepackage0440-72000440-7200-90IInactivated by FDA2026-10-05
excluded packagepackage0440-72000440-7200-91IInactivated by FDA2026-10-05
excluded packagepackage0440-72000440-7200-92IInactivated by FDA2026-10-05

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 3 · 154 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 packagepackage0440-7200-81d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0440-7200-92d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0440-7200-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0440-7200-91d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0440-7200-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0440-7200-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0440-7200-81f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0440-7200-92f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0440-7200-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0440-7200-91f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0440-7200-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0440-7200-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0440-7200-812ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0440-7200-922ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0440-7200-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0440-7200-912ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0440-7200-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0440-7200-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0440-7200-81a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0440-7200-92a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0440-7200-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0440-7200-91a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0440-7200-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0440-7200-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0440-7200-81cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0440-7200-92cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0440-7200-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0440-7200-91cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0440-7200-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0440-7200-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0440-7200-81cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0440-7200-92cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0440-7200-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0440-7200-91cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0440-7200-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0440-7200-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0440-7200-81302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0440-7200-92302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0440-7200-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0440-7200-91302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0440-7200-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0440-7200-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0440-7200-81ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0440-7200-92ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0440-7200-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0440-7200-91ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0440-7200-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0440-7200-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0440-7200-810efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0440-7200-920efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0440-7200-300efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077455-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-19
A077455-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-12
A077455-003BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-19

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-1284e616aacf4f…
2026-09-14 22:38:342026-08A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-1984e616aacf4f…
2026-08-18 06:07:402026-07A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-12caaa826d4ba7…
2026-08-18 06:07:402026-07A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077455-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2008-03-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077455-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-07-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077455-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-07-19301d65b070ca…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A077455-001AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077455-002AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077455-003AB1174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A077455-001AB113f01610625f2…
2019-12-14 00:12 UTC2019-12A077455-002AB113f01610625f2…
2019-12-14 00:12 UTC2019-12A077455-003AB113f01610625f2…
2019-09-15 20:21 UTC2019-09A077455-001AB11b00525d2431f…
2019-09-15 20:21 UTC2019-09A077455-002AB11b00525d2431f…
2019-09-15 20:21 UTC2019-09A077455-003AB11b00525d2431f…
2019-07-19 19:46 UTC2019-07A077455-001AB11ea99ee380514…
2019-07-19 19:46 UTC2019-07A077455-002AB11ea99ee380514…
2019-07-19 19:46 UTC2019-07A077455-003AB11ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-7200-30Bupropion Hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301
0440-7200-60Bupropion Hydrochloride60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE601
0440-7200-81Bupropion Hydrochloride300 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3001
0440-7200-90Bupropion Hydrochloride90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901
0440-7200-91Bupropion Hydrochloride120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1201
0440-7200-92Bupropion Hydrochloride180 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-7200BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [LIBERTY PHARMACEUTICALS, INC.]1Legacy NDC, 6 package rows20160810_f9166a47-71ee-4e0b-b0e5-045df043d908.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNf9166a47-71ee-4e0b-b0e5-045df043d9081
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDf9166a47-71ee-4e0b-b0e5-045df043d9081
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYf9166a47-71ee-4e0b-b0e5-045df043d9081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-7200-300044072003030 in 1 BOTTLEHistorical
0440-7200-600044072006060 in 1 BOTTLEHistorical
0440-7200-8100440720081300 in 1 BOTTLEHistorical
0440-7200-900044072009090 in 1 BOTTLEHistorical
0440-7200-9100440720091120 in 1 BOTTLEHistorical
0440-7200-9200440720092180 in 1 BOTTLEHistorical