Bupropion Hydrochloride
- Product NDC
- 0591-3541
- Requested package NDC
- 0591-3541-01
- 11-digit product format
- 005913541
- Labeler code
- 0591
- Product ID
- 0591-3541_46100e89-6164-4144-8f8b-761371282a01
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupropion hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA079095
- Marketing category
- ANDA
- Marketing start
- 2009-07-02
- 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
- 2027-12-31
- Current FDA listing
- Yes
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.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A079095-001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | |
| A079095-002 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | |
| A079095-003 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A079095-001 | AB1 |
| A079095-002 | AB1 |
| A079095-003 | AB1 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A079095-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079095-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079095-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079095-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079095-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079095-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079095-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079095-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079095-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079095-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079095-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079095-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079095-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079095-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079095-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079095-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079095-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079095-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079095-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079095-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079095-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079095-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079095-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079095-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079095-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079095-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079095-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A079095-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A079095-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A079095-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079095-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079095-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079095-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079095-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079095-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079095-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079095-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079095-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079095-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A079095-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2009-03-24 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A079095-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079095-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079095-003 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079095-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079095-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079095-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A079095-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079095-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079095-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079095-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079095-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079095-003 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079095-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079095-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079095-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079095-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079095-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079095-003 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079095-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079095-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079095-003 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079095-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079095-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079095-003 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079095-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079095-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079095-003 | AB1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A079095-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A079095-002 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A079095-003 | AB1 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079095-001 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079095-002 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079095-003 | AB1 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079095-001 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079095-002 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079095-003 | AB1 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079095-001 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079095-002 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079095-003 | AB1 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A079095-001 | AB1 | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bupropion Hydrochloride
- Brand name suffix
- SR
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUPROPION HYDROCHLORIDE | 150 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| ZG7E5POY8O | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| cec41945-8d64-4793-8784-4c2b8ec37b0f | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4eceb285-f3c7-4092-a21a-4c9f3169f20c | Product name | 5 | 20260220 |
| 548ba7fd-fd0c-4a21-b2b0-d01bf93143b8 | Product name | 3 | 20240209 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| b8ee525f-67fb-39fb-91da-7e47ac54581d | Product name | 5 | 20200611 |
| 98e65af1-f5d0-75d5-c930-f8a4ce4c3284 | Product name | 9 | 20190211 |
| e4d463bc-c674-43cb-be06-82786f310d01 | Product name | 1 | 20150326 |
| 0916dcfb-331f-89b1-8eac-6f7dc76d82da | Product name | 1 | 20140508 |
| d7fc3d53-5a6c-de82-2808-1780f175f17e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0591-3541-01 | Bupropion HydrochlorideSR | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 100 | 55 | |
| 0591-3541-05 | Bupropion HydrochlorideSR | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 500 | 55 | |
| 0591-3541-25 | Bupropion HydrochlorideSR | 250 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 250 | 55 | |
| 0591-3541-60 | Bupropion HydrochlorideSR | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 60 | 55 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0591-3541-05 | EA - Each | 0591-3541 | 32cd42b3-13a2-4407-822f-eb82f24304da | 1 | 2012-07-24 |
| 0591-3541-25 | EA - Each | 0591-3541 | ba618f97-e8a3-43e9-bb6b-1d5761c36cae | 1 | 2012-07-24 |
| 0591-3541-60 | EA - Each | 0591-3541 | cfe10dcc-ff87-4afb-ac9c-ff179deead04 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0591-3541 | BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 53 | Current NDC, Legacy NDC, 4 package rows | 20250406_cec41945-8d64-4793-8784-4c2b8ec37b0f.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| BuPROPion Hydrochloride | BUPROPION HYDROCHLORIDE | American Health Packaging | 1af890f7-1db8-4dd2-bf66-2b1e0c93a3d8 | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | 079095 ANDA079095 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | f58ce435-b124-4519-98d8-de2d00f61b01 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | 079095 ANDA079095 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Actavis Pharma, Inc. | cec41945-8d64-4793-8784-4c2b8ec37b0f | 2025-11-11 | Boxed warning, Warnings, Adverse reactions | 079095 ANDA079095 0591-3541 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | ec8c699f-a8de-4e5a-a223-8de3f5dfe20d | 2024-10-08 | Boxed warning, Warnings, Adverse reactions | 079095 ANDA079095 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Proficient Rx LP | b59d950c-341f-45f1-b5b2-d64ccc799580 | 2024-05-01 | Boxed warning, Warnings, Adverse reactions | 079095 ANDA079095 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Proficient Rx LP | 13770e60-117c-4814-93bb-9bc41a042a20 | 2022-05-01 | Boxed warning, Warnings, Adverse reactions | 079095 ANDA079095 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Proficient Rx LP | a165869a-9bc4-4987-babe-a77fad78c38f | 2020-02-01 | Boxed warning, Warnings, Adverse reactions | 079095 ANDA079095 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 993518 | buPROPion HCl 150 MG 12HR Extended Release Oral Tablet | PSN | f58ce435-b124-4519-98d8-de2d00f61b01 | 59 |
| 993518 | 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet | SCD | f58ce435-b124-4519-98d8-de2d00f61b01 | 59 |
| 993518 | bupropion HCl 150 MG 12 HR Extended Release Oral Tablet | SY | f58ce435-b124-4519-98d8-de2d00f61b01 | 59 |
| 993503 | buPROPion HCl 100 MG 12HR Extended Release Oral Tablet | PSN | cec41945-8d64-4793-8784-4c2b8ec37b0f | 55 |
| 993518 | buPROPion HCl 150 MG 12HR Extended Release Oral Tablet | PSN | cec41945-8d64-4793-8784-4c2b8ec37b0f | 55 |
| 993536 | buPROPion HCl 200 MG 12HR Extended Release Oral Tablet | PSN | cec41945-8d64-4793-8784-4c2b8ec37b0f | 55 |
| 993503 | 12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet | SCD | cec41945-8d64-4793-8784-4c2b8ec37b0f | 55 |
| 993518 | 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet | SCD | cec41945-8d64-4793-8784-4c2b8ec37b0f | 55 |
| 993536 | 12 HR bupropion hydrochloride 200 MG Extended Release Oral Tablet | SCD | cec41945-8d64-4793-8784-4c2b8ec37b0f | 55 |
| 993503 | bupropion HCl 100 MG 12 HR Extended Release Oral Tablet | SY | cec41945-8d64-4793-8784-4c2b8ec37b0f | 55 |
| 993518 | bupropion HCl 150 MG 12 HR Extended Release Oral Tablet | SY | cec41945-8d64-4793-8784-4c2b8ec37b0f | 55 |
| 993536 | bupropion hydrochloride 200 MG 12 HR Extended Release Oral Tablet | SY | cec41945-8d64-4793-8784-4c2b8ec37b0f | 55 |
| 993503 | buPROPion HCl 100 MG 12HR Extended Release Oral Tablet | PSN | 1af890f7-1db8-4dd2-bf66-2b1e0c93a3d8 | 11 |
| 993518 | buPROPion HCl 150 MG 12HR Extended Release Oral Tablet | PSN | ec8c699f-a8de-4e5a-a223-8de3f5dfe20d | 11 |
| 993518 | buPROPion HCl 150 MG 12HR Extended Release Oral Tablet | PSN | 1af890f7-1db8-4dd2-bf66-2b1e0c93a3d8 | 11 |
| 993503 | 12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet | SCD | 1af890f7-1db8-4dd2-bf66-2b1e0c93a3d8 | 11 |
| 993518 | 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet | SCD | ec8c699f-a8de-4e5a-a223-8de3f5dfe20d | 11 |
| 993518 | 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet | SCD | 1af890f7-1db8-4dd2-bf66-2b1e0c93a3d8 | 11 |
| 993503 | bupropion HCl 100 MG 12 HR Extended Release Oral Tablet | SY | 1af890f7-1db8-4dd2-bf66-2b1e0c93a3d8 | 11 |
| 993518 | bupropion HCl 150 MG 12 HR Extended Release Oral Tablet | SY | ec8c699f-a8de-4e5a-a223-8de3f5dfe20d | 11 |
| 993518 | bupropion HCl 150 MG 12 HR Extended Release Oral Tablet | SY | 1af890f7-1db8-4dd2-bf66-2b1e0c93a3d8 | 11 |
| 993518 | buPROPion HCl 150 MG 12HR Extended Release Oral Tablet | PSN | 13770e60-117c-4814-93bb-9bc41a042a20 | 5 |
| 993518 | buPROPion HCl 150 MG 12HR Extended Release Oral Tablet | PSN | 53f55247-ba8c-4960-9981-05ad1b501643 | 5 |
| 993518 | 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet | SCD | 53f55247-ba8c-4960-9981-05ad1b501643 | 5 |
| 993518 | 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet | SCD | 13770e60-117c-4814-93bb-9bc41a042a20 | 5 |
| 993518 | bupropion HCl 150 MG 12 HR Extended Release Oral Tablet | SY | 53f55247-ba8c-4960-9981-05ad1b501643 | 5 |
| 993518 | bupropion HCl 150 MG 12 HR Extended Release Oral Tablet | SY | 13770e60-117c-4814-93bb-9bc41a042a20 | 5 |
| 993518 | buPROPion HCl 150 MG 12HR Extended Release Oral Tablet | PSN | 9c6e2044-c040-403c-bcd6-99ca1e6bba73 | 3 |
| 993518 | buPROPion HCl 150 MG 12HR Extended Release Oral Tablet | PSN | 8772b5e3-d442-3c98-e053-2a95a90a9ce0 | 3 |
| 993518 | 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet | SCD | 9c6e2044-c040-403c-bcd6-99ca1e6bba73 | 3 |
| 993518 | 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet | SCD | 8772b5e3-d442-3c98-e053-2a95a90a9ce0 | 3 |
| 993518 | bupropion HCl 150 MG 12 HR Extended Release Oral Tablet | SY | 9c6e2044-c040-403c-bcd6-99ca1e6bba73 | 3 |
| 993518 | bupropion HCl 150 MG 12 HR Extended Release Oral Tablet | SY | 8772b5e3-d442-3c98-e053-2a95a90a9ce0 | 3 |
| 993518 | buPROPion HCl 150 MG 12HR Extended Release Oral Tablet | PSN | edc9d7ad-5ba2-4a3d-91a3-df9042fdc3dd | 2 |
| 993518 | 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet | SCD | edc9d7ad-5ba2-4a3d-91a3-df9042fdc3dd | 2 |
| 993518 | bupropion HCl 150 MG 12 HR Extended Release Oral Tablet | SY | edc9d7ad-5ba2-4a3d-91a3-df9042fdc3dd | 2 |
| 993503 | buPROPion HCl 100 MG 12HR Extended Release Oral Tablet | PSN | e3fb04de-2a55-456f-8ecc-ac44dc8e5b5a | 1 |
| 993503 | buPROPion HCl 100 MG 12HR Extended Release Oral Tablet | PSN | 02500709-7f2c-4251-bd8c-94ab6cdadd4c | 1 |
| 993503 | buPROPion HCl 100 MG 12HR Extended Release Oral Tablet | PSN | 3b41a8f8-34f4-4a38-9013-9cefafd6009c | 1 |
| 993518 | buPROPion HCl 150 MG 12HR Extended Release Oral Tablet | PSN | e3fb04de-2a55-456f-8ecc-ac44dc8e5b5a | 1 |
| 993518 | buPROPion HCl 150 MG 12HR Extended Release Oral Tablet | PSN | 02500709-7f2c-4251-bd8c-94ab6cdadd4c | 1 |
| 993518 | buPROPion HCl 150 MG 12HR Extended Release Oral Tablet | PSN | 3b41a8f8-34f4-4a38-9013-9cefafd6009c | 1 |
| 993536 | buPROPion HCl 200 MG 12HR Extended Release Oral Tablet | PSN | e3fb04de-2a55-456f-8ecc-ac44dc8e5b5a | 1 |
| 993503 | 12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet | SCD | e3fb04de-2a55-456f-8ecc-ac44dc8e5b5a | 1 |
| 993503 | 12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet | SCD | 02500709-7f2c-4251-bd8c-94ab6cdadd4c | 1 |
| 993503 | 12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet | SCD | 3b41a8f8-34f4-4a38-9013-9cefafd6009c | 1 |
| 993518 | 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet | SCD | 3b41a8f8-34f4-4a38-9013-9cefafd6009c | 1 |
| 993518 | 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet | SCD | e3fb04de-2a55-456f-8ecc-ac44dc8e5b5a | 1 |
| 993518 | 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet | SCD | 02500709-7f2c-4251-bd8c-94ab6cdadd4c | 1 |
| 993536 | 12 HR bupropion hydrochloride 200 MG Extended Release Oral Tablet | SCD | e3fb04de-2a55-456f-8ecc-ac44dc8e5b5a | 1 |
| 993503 | bupropion HCl 100 MG 12 HR Extended Release Oral Tablet | SY | e3fb04de-2a55-456f-8ecc-ac44dc8e5b5a | 1 |
| 993503 | bupropion HCl 100 MG 12 HR Extended Release Oral Tablet | SY | 02500709-7f2c-4251-bd8c-94ab6cdadd4c | 1 |
| 993503 | bupropion HCl 100 MG 12 HR Extended Release Oral Tablet | SY | 3b41a8f8-34f4-4a38-9013-9cefafd6009c | 1 |
| 993518 | bupropion HCl 150 MG 12 HR Extended Release Oral Tablet | SY | 02500709-7f2c-4251-bd8c-94ab6cdadd4c | 1 |
| 993518 | bupropion HCl 150 MG 12 HR Extended Release Oral Tablet | SY | 3b41a8f8-34f4-4a38-9013-9cefafd6009c | 1 |
| 993518 | bupropion HCl 150 MG 12 HR Extended Release Oral Tablet | SY | e3fb04de-2a55-456f-8ecc-ac44dc8e5b5a | 1 |
| 993536 | bupropion hydrochloride 200 MG 12 HR Extended Release Oral Tablet | SY | e3fb04de-2a55-456f-8ecc-ac44dc8e5b5a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0591-3541-01 | 00591354101 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3541-01) | 2009-07-02 | 0000-00-00 | No | No | Current |