Bupropion Hydrochloride

Product NDC
64980-201
11-digit product format
649800201
Labeler code
64980
Product ID
64980-201_74120afa-f695-48b1-9eef-36d58d56b906
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharmaceuticals, Inc.
Application
ANDA203013
Marketing category
ANDA
Marketing start
2018-06-18
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
75 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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64980-201DDiscontinued by firm2026-08-03
excluded packagepackage64980-20164980-201-01DDiscontinued by firm2026-08-03
excluded packagepackage64980-20164980-201-05DDiscontinued 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 · 36 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 packagepackage64980-201-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64980-201-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64980-201-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64980-201-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64980-201-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64980-201-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64980-201-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64980-201-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64980-201-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64980-201-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64980-201-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64980-201-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64980-201-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64980-201-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64980-201-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64980-201-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64980-201-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64980-201-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64980-201-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64980-201-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64980-201-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64980-201-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64980-201-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64980-201-01557ba5c1ecfa…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
A203013-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2018-06-08
A203013-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2018-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203013-001AB
A203013-002AB

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 UTC2026-02A203013-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2018-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203013-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2018-06-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203013-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2018-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203013-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2018-06-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A203013-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2018-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203013-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2018-06-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203013-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2018-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203013-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2018-06-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203013-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2018-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203013-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2018-06-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203013-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2018-06-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203013-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2018-06-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203013-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2018-06-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203013-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2018-06-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203013-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2018-06-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203013-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2018-06-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203013-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2018-06-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203013-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2018-06-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203013-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2018-06-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A203013-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2018-06-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203013-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2018-06-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203013-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2018-06-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203013-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2018-06-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203013-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2018-06-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203013-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2018-06-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203013-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2018-06-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203013-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2018-06-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203013-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2018-06-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203013-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2018-06-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203013-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2018-06-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203013-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2018-06-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203013-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2018-06-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203013-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2018-06-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203013-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2018-06-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203013-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2018-06-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203013-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2018-06-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203013-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2018-06-08bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203013-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2018-06-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203013-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2018-06-08782e0a99824c…
2021-12-28 21:50 UTC2021-12A203013-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2018-06-08782e0a99824c…

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 UTC2026-02A203013-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203013-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203013-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203013-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203013-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203013-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203013-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203013-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203013-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203013-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203013-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203013-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203013-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203013-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203013-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203013-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203013-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203013-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203013-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203013-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203013-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203013-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203013-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203013-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203013-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203013-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203013-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203013-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203013-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203013-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203013-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203013-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203013-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203013-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203013-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203013-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203013-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203013-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203013-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203013-002AB1782e0a99824c…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-201-01EA - Each64980-201b7af96f7-19ac-497d-a8db-4ef5cedbc0d612018-11-06

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.990587bd-4c7d-4a36-8a38-3104648ab3a22026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203013
application number: ANDA203013
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.81d251aa-a8e8-493e-94ed-12f6fb8902e62025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203013
application number: ANDA203013
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAlembic Pharmaceuticals Inc.b303a0ad-5971-44ab-937c-bcf3ff6503582025-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203013
application number: ANDA203013
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAlembic Pharmaceuticals Limitedef0bb8f2-7710-4236-8b47-57b74c8bca3e2024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203013
application number: ANDA203013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993691buPROPion HCl 75 MG Oral TabletPSN6a300adb-b1c2-4250-bd15-272b04699edd1
993691bupropion hydrochloride 75 MG Oral TabletSCD6a300adb-b1c2-4250-bd15-272b04699edd1
993691bupropion HCl 75 MG Oral TabletSY6a300adb-b1c2-4250-bd15-272b04699edd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64980-201-0164980020101100 TABLET, FILM COATED in 1 BOTTLE (64980-201-01) 2018-06-180000-00-00NoNoCurrent
64980-201-0564980020105500 TABLET, FILM COATED in 1 BOTTLE (64980-201-05) 2018-06-180000-00-00NoNoCurrent