FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
67544-299
Requested package NDC
67544-299-30
11-digit product format
675440299
Labeler code
67544
Product ID
67544-299_16d1151d-57e4-40ba-96a6-b5c0bc1f1d46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075932
Marketing category
ANDA
Marketing start
2004-03-22
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
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 packagepackage67544-29967544-299-30IInactivated by FDA2026-08-03

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 · 15 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075932-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-25
A075932-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-22
A075932-003BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A075932-001AB1
A075932-002AB1
A075932-003AB1

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-258072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075932-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075932-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075932-003AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075932-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075932-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075932-003AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075932-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075932-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075932-003AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075932-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075932-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075932-003AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075932-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075932-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075932-003AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075932-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075932-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075932-003AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075932-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075932-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075932-003AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075932-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075932-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075932-003AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075932-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075932-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075932-003AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075932-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A075932-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A075932-003AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075932-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075932-002AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075932-003AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075932-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075932-002AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075932-003AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075932-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075932-002AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075932-003AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075932-001AB118072bd15b7f6…

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#

NDC, Related label table
NDCRelated label
67544-299-30These highlights do not include all the information needed to use BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) . BuPROPion HYDROCHLORIDE extended-release tablets (SR), for oral use . Initial U.S. Approval: 1985
67544-299-53These highlights do not include all the information needed to use BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) . BuPROPion HYDROCHLORIDE extended-release tablets (SR), for oral use . Initial U.S. Approval: 1985
67544-299-60These highlights do not include all the information needed to use BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) . BuPROPion HYDROCHLORIDE extended-release tablets (SR), for oral use . Initial U.S. Approval: 1985
67544-299-80These highlights do not include all the information needed to use BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) . BuPROPion HYDROCHLORIDE extended-release tablets (SR), for oral use . Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-299-30Bupropion Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE302
67544-299-53Bupropion Hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE602
67544-299-60Bupropion Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE902
67544-299-80Bupropion Hydrochloride180 in 1 BOTTLETABLET, EXTENDED RELEASE1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-299-30EA - Each67544-2999126c090-77a4-4e5e-909c-ff2f2d76aa2e12018-01-12
67544-299-60EA - Each67544-29915c58054-936a-4b66-b3b9-defac0462ec412018-01-12
67544-299-80EA - Each67544-29914e1ba59-0208-4df9-9728-c9ed6b223d5012018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-299BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 4 package rows20191224_8cf8931a-0891-4adb-aeb6-1c91ed9b7de1.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEEpic Pharma LLC9fb44e96-6160-4a4a-90cb-91764c0dcd892024-06-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075932
application number: ANDA075932
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEA-S Medication Solutions87dac2ee-732c-465b-8ffe-e5aeba4214252024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075932
application number: ANDA075932

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN8cf8931a-0891-4adb-aeb6-1c91ed9b7de12
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD8cf8931a-0891-4adb-aeb6-1c91ed9b7de12
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY8cf8931a-0891-4adb-aeb6-1c91ed9b7de12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67544-299-306754402993030 TABLET, EXTENDED RELEASE in 1 BOTTLE (67544-299-30) 2014-06-100000-00-00NoNoCurrent