Bupropion hydrochloride (XL)
- Product NDC
- 0781-5529
- 11-digit product format
- 007815529
- Labeler code
- 0781
- Product ID
- 0781-5529_a7fcc3be-3698-456b-ac4c-860ef32f153a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sandoz Inc.
- Application
- ANDA208652
- Marketing category
- ANDA
- Marketing start
- 2018-01-08
- Marketing end
- 0000-00-00
- Substance
- BUPROPION HYDROCHLORIDE
- Active strength
- 300 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
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 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0781-5529-10 | EA - Each | 0781-5529 | 0da804e0-c033-4900-8c98-9de0cd09e33b | 1 | 2018-03-08 |
| 0781-5529-31 | EA - Each | 0781-5529 | e446690e-1a48-4bd2-bc35-a868e721dd17 | 1 | 2018-03-08 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 993541 | buPROPion HCl 150 MG 24HR Extended Release Oral Tablet | PSN | 7e8ffc37-4bc2-4844-adb5-c7bbc318c623 | 6 |
| 993557 | buPROPion HCl 300 MG 24HR Extended Release Oral Tablet | PSN | 7e8ffc37-4bc2-4844-adb5-c7bbc318c623 | 6 |
| 993541 | 24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet | SCD | 7e8ffc37-4bc2-4844-adb5-c7bbc318c623 | 6 |
| 993557 | 24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet | SCD | 7e8ffc37-4bc2-4844-adb5-c7bbc318c623 | 6 |
| 993541 | bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet | SY | 7e8ffc37-4bc2-4844-adb5-c7bbc318c623 | 6 |
| 993557 | bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet | SY | 7e8ffc37-4bc2-4844-adb5-c7bbc318c623 | 6 |
| 993557 | buPROPion HCl 300 MG 24HR Extended Release Oral Tablet | PSN | fe1db54b-d9ef-40b4-bc89-1369be50936a | 3 |
| 993557 | 24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet | SCD | fe1db54b-d9ef-40b4-bc89-1369be50936a | 3 |
| 993557 | bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet | SY | fe1db54b-d9ef-40b4-bc89-1369be50936a | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0781-5529-10 | 00781552910 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5529-10) | 2018-01-08 | 0000-00-00 | No | No | Current |
| 0781-5529-31 | 00781552931 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5529-31) | 2018-01-08 | 0000-00-00 | No | No | Current |