Bupropion hydrochloride (XL)
- Product NDC
- 50090-4169
- 11-digit product format
- 500904169
- Labeler code
- 50090
- Product ID
- 50090-4169_2e9e06b4-ad60-4bb9-866d-6b05c23a745f
- 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
- 2020-12-31
- 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 |
|---|
| 50090-4169-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0783-0266-e053-dadaa90a7c1a | 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 |
| 50090-4169-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0783-0266-e053-dadaa90a7c1a | 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 |
| 50090-4169-2 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0783-0266-e053-dadaa90a7c1a | 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 |
|---|
| 50090-4169-0 | Bupropion hydrochloride (XL) | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 4 |
| 50090-4169-1 | Bupropion hydrochloride (XL) | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | | 4 |
| 50090-4169-2 | Bupropion hydrochloride (XL) | 60 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 60 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-4169 | BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS] | 4 | Legacy NDC, 3 package rows | 20190427_922095b9-54ee-4a7f-91ad-40949f81c642.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 |
|---|
| 50090-4169-0 | 50090416900 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4169-0) | 2019-02-27 | 0000-00-00 | No | No | Current |
| 50090-4169-1 | 50090416901 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-4169-1) | 2018-01-08 | 0000-00-00 | No | No | Current |
| 50090-4169-2 | 50090416902 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-4169-2) | 2018-01-08 | 0000-00-00 | No | No | Current |