Bupropion Hydrochloride

Product NDC
70518-1584
11-digit product format
705181584
Labeler code
70518
Product ID
70518-1584_ec58ca14-f2ec-53f9-e053-2995a90a205e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076143
Marketing category
ANDA
Marketing start
2018-10-24
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-1584DDiscontinued by firm2026-10-05
excluded packagepackage70518-158470518-1584-0DDiscontinued by firm2026-10-05
excluded packagepackage70518-158470518-1584-1DDiscontinued by firm2026-10-05

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 1 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct70518-1584DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-158470518-1584-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-158470518-1584-0DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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

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
A076143-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-17
A076143-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076143-001AB
A076143-002AB

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-1784e616aacf4f…
2026-09-14 22:38:342026-08A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-1784e616aacf4f…
2026-08-18 06:07:402026-07A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-17caaa826d4ba7…
2026-08-18 06:07:402026-07A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-1774a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076143-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A076143-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A076143-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076143-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076143-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076143-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076143-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076143-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076143-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076143-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076143-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076143-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076143-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076143-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076143-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076143-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076143-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076143-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076143-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076143-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076143-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076143-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076143-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076143-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076143-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076143-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076143-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076143-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076143-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076143-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076143-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076143-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076143-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076143-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076143-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076143-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076143-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076143-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076143-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076143-002AB174a2ff9319b5…

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1584BUPROPION HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]13Legacy NDC20250226_fdbcc274-c343-4461-9db9-6ff1be15d727.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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEApotex Corp86530199-999b-9f92-b1bc-b8515ec829f32026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECoupler LLC5829a2aa-4845-b58b-e063-6294a90ad2f42026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.867d3876-6974-4e89-bc45-9e60e84b401c2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDESt. Mary's Medical Park Pharmacy362504fd-2f0a-c097-e063-6394a90ac0fc2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAmerican Health Packaging88c980c8-aaa8-4378-9ac2-24d588640caa2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b5c12c9a-62eb-481a-8099-7ad35242f7bf2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECardinal Health 107, LLC64934ca2-5655-45a2-9016-ad65b5abf5d32026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECoupler LLC5038440c-1f32-715a-e063-6294a90a889d2026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECardinal Health 107, LLCec4d2256-0340-4166-90ee-c264eef3ac822026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals Inc.eabb54b7-164c-4de8-b91a-f2e65637b5fc2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEMajor Pharmaceuticalsb127d3fc-be5e-4c12-8026-205766bf8e7f2026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAvPAKbcb4ef83-f272-4090-8547-9aaf4ab636672026-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBluePoint Laboratories7d035056-44ab-444d-9d27-125b3f5711402025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEGolden State Medical Supply, Inc.9490d611-b679-45c7-e053-2a95a90afb872025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepackf566f8b5-b3c1-4234-88bd-59a7b8dc801a2025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepackfa5fa0d8-d27f-44e1-8868-dfa7206524e22025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack2a13267f-c47f-4791-a8f9-4bbb5c8040272025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack1d722dc2-7909-454e-b989-0956770790442025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDENuCare Pharmaceuticals,Inc.d1043c87-0abe-ee8e-e053-2a95a90a419a2025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HCLBUPROPION HCLDirect_Rxf820ad7d-3c88-4a4f-e053-6294a90aef7b2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1584-07051815840030 TABLET, FILM COATED in 1 BLISTER PACK (70518-1584-0) 2018-10-240000-00-00NoNoCurrent
70518-1584-17051815840190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1584-1) 2019-02-190000-00-00NoNoCurrent