bupropion Hydrochloride

Product NDC
71335-1192
Requested package NDC
71335-1192-3
11-digit product format
713351192
Labeler code
71335
Product ID
71335-1192_fc929c15-d3b5-46b6-ac26-db87778c7fa5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206975
Marketing category
ANDA
Marketing start
2016-08-19
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
100 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
2023-12-31
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 packagepackage71335-119271335-1192-3DDiscontinued by firm2026-08-03
excluded packagepackage71335-119271335-1192-3DDiscontinued 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, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
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
A206975-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-19
A206975-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206975-001AB
A206975-002AB

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 UTC2026-02A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-19782e0a99824c…
2021-12-28 21:50 UTC2021-12A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-19782e0a99824c…

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 UTC2026-02A206975-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206975-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206975-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206975-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206975-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206975-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206975-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206975-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206975-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206975-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206975-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206975-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206975-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206975-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206975-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206975-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206975-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206975-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206975-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206975-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206975-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206975-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206975-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206975-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206975-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206975-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206975-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206975-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206975-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206975-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206975-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206975-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206975-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206975-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206975-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206975-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206975-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206975-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206975-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A206975-002AB1782e0a99824c…

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bupropion HydrochlorideBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.434aacf8-87f1-44fc-a66b-92ae0022de0e2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
bupropion HydrochlorideBUPROPION HYDROCHLORIDECoupler LLC507112bd-a082-e85a-e063-6294a90ab2ac2026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEMAJOR PHARMACEUTICALS3c6b5ab4-9671-4fcd-8b4c-7f230dcfe6c92026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
bupropion HydrochlorideBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.90cc4f07-e0a3-4d50-a10a-8f6a7f9c51402026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
bupropion HydrochlorideBUPROPION HYDROCHLORIDENorthwind Health Company, LLCd9bbacb3-63b4-2922-e053-2a95a90a60852026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepacke2a988f2-f8d3-4de0-b9f1-49d8c2e4180f2025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepacke4c450ff-32bd-4359-8449-0b0d0b89a78c2025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECoupler LLC3eec57be-b8ae-cdf8-e063-6394a90a694d2025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
bupropion HydrochlorideBUPROPION HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.9196568e-aec8-4d56-993e-4cbb78d4a3a62025-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack744f7394-aac9-4864-9436-e5b0b35a61482025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack144379e1-93b7-41c1-bc3a-7bdec5afa3092025-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECoupler LLC35a873c5-4aa8-b3c7-e063-6394a90a35ec2025-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC334e5635-e4cc-cf2a-e063-6294a90ae1e12025-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack4971c3cb-07c4-4c65-a16a-f1700e5231472025-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepackbd99969d-03d5-4609-88e8-a9ae93a839072025-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
bupropion HydrochlorideBUPROPION HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd0eada89-e302-4ba3-bef0-e8c69af8206e2025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEChartwell RX, LLC620fab1e-aafb-444d-ab81-63281cd139c52024-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1192-371335119203100 TABLET in 1 BOTTLE (71335-1192-3) 100 tablet2022-02-230000-00-00NoNoCurrent