Bupropion hydrochloride (XL)
- Product NDC
- 50090-6173
- 11-digit product format
- 500906173
- Labeler code
- 50090
- Product ID
- 50090-6173_cf05be2e-af46-4b46-a23f-134c4f9e21e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA208652
- Marketing category
- ANDA
- Marketing start
- 2018-01-08
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-6173-0 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0644-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, (XL). BUPROPION HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1985 |
| 50090-6173-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0644-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, (XL). BUPROPION HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1985 |
| 50090-6173-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0644-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, (XL). BUPROPION HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1985 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-6173-0 | Bupropion hydrochloride (XL) | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 3 |
| 50090-6173-1 | Bupropion hydrochloride (XL) | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 3 |
| 50090-6173-2 | Bupropion hydrochloride (XL) | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-6173 | BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS] | 3 | Legacy NDC, 3 package rows | 20221029_1f3c957a-4f52-4302-b2c3-c1f9c5ac168d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-6173-0 | 50090617300 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6173-0) | 2022-10-14 | 0000-00-00 | No | No | Current |
| 50090-6173-1 | 50090617301 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6173-1) | 2022-10-14 | 0000-00-00 | No | No | Current |
| 50090-6173-2 | 50090617302 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6173-2) | 2022-10-26 | 0000-00-00 | No | No | Current |