BUPROPION HYDROCHLORIDE

Product NDC
61919-037
11-digit product format
619190037
Labeler code
61919
Product ID
61919-037_94f405d3-4f79-5405-e053-2995a90a9bd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DirectRX
Application
ANDA075584
Marketing category
ANDA
Marketing start
2015-11-25
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 productproduct61919-037IInactivated by FDA2026-08-17
excluded packagepackage61919-03761919-037-30IInactivated by FDA2026-08-17
excluded packagepackage61919-03761919-037-60IInactivated by FDA2026-08-17

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 · 45 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 packagepackage61919-037-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-037-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-037-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-037-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-037-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-037-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-037-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-037-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-037-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-037-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-037-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-037-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-037-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-037-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-037-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-037-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-037-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-037-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-037-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-037-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-037-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-037-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-037-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-037-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-037-608af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-037-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-037-60834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-037-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-037-601332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-037-301332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075584-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-02-07
A075584-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-02-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075584-001AB
A075584-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075584-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-02-07caaa826d4ba7…
2026-08-18 06:07:402026-07A075584-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-02-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075584-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075584-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-02-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075584-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-02-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075584-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-02-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A075584-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-02-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075584-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-02-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075584-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-02-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075584-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-02-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075584-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-02-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075584-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-02-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075584-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-02-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075584-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-02-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075584-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-02-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075584-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-02-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075584-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-02-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075584-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-02-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075584-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-02-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075584-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-02-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075584-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-02-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A075584-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-02-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075584-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-02-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075584-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-02-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075584-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-02-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075584-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-02-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075584-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-02-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075584-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-02-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075584-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-02-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075584-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-02-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075584-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-02-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075584-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-02-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075584-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-02-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075584-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-02-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075584-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-02-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075584-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-02-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075584-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-02-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075584-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-02-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075584-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2000-02-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075584-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2000-02-07bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075584-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075584-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075584-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075584-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075584-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075584-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075584-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075584-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075584-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075584-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075584-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075584-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075584-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075584-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075584-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075584-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075584-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075584-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075584-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075584-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075584-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075584-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075584-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075584-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075584-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075584-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075584-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075584-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075584-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075584-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075584-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075584-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075584-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075584-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075584-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075584-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075584-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075584-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075584-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075584-002AB1bb7c543d1eb4…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-037-302023-01-30C16284748780-1f386c649-d08a-0266-e053-dadaa90a7c1aBUPROPION HYDROCHLORIDE
61919-037-602023-01-30C16284748780-1f386c649-d08a-0266-e053-dadaa90a7c1aBUPROPION HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-037-30BUPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED302
61919-037-60BUPROPION HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-037-60EA - Each61919-0378a45da2b-4983-4622-8355-f6c33a7e3e3b12016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET [DIRECTRX]1
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE TABLET [DIRECTRX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBUPROPION HYDROCHLORIDE TABLET [DIRECTRX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABUPROPION HYDROCHLORIDE TABLET [DIRECTRX]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WBUPROPION HYDROCHLORIDE TABLET [DIRECTRX]1
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10BUPROPION HYDROCHLORIDE TABLET [DIRECTRX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUPROPION HYDROCHLORIDE TABLET [DIRECTRX]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE TABLET [DIRECTRX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE TABLET [DIRECTRX]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUPROPION HYDROCHLORIDE TABLET [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-037BUPROPION HYDROCHLORIDE TABLET, FILM COATED [DIRECTRX]2Legacy NDC, 2 package rows20191101_2563ea9f-6e29-2747-e054-00144ff88e88.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAmici Pharma, Inc.fbb587fa-75c0-4f4d-8eaf-f0e7ba8b5c752026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075584
application number: ANDA075584

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993691buPROPion HCl 75 MG Oral TabletPSN2563ea9f-6e29-2747-e054-00144ff88e882
993691bupropion hydrochloride 75 MG Oral TabletSCD2563ea9f-6e29-2747-e054-00144ff88e882
993691bupropion HCl 75 MG Oral TabletSY2563ea9f-6e29-2747-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-037-306191900373030 TABLET, FILM COATED in 1 BOTTLE (61919-037-30) 2015-11-250000-00-00NoNoCurrent
61919-037-606191900376060 TABLET, FILM COATED in 1 BOTTLE (61919-037-60) 2015-11-250000-00-00NoNoCurrent