Bupropion Hydrochloride
- Product NDC
- 50090-4747
- 11-digit product format
- 500904747
- Labeler code
- 50090
- Product ID
- 50090-4747_238517b6-07f6-40c8-9b93-d75e839265a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA090693
- Marketing category
- ANDA
- Marketing start
- 2017-06-14
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bupropion Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPROPION HYDROCHLORIDE | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ZG7E5POY8O |
| Rxcui | 993541 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-4747-0 | 2023-12-11 | C162847 | 48780-1 | f386c64a-0c8b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS. BUPROPION hydrochloride extended-release tablets, for oral use Initial U.S. Approval: 1985 |
| 50090-4747-1 | 2023-12-11 | C162847 | 48780-1 | f386c64a-0c8b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS. BUPROPION hydrochloride extended-release tablets, for oral use Initial U.S. Approval: 1985 |
| 50090-4747-2 | 2023-12-11 | C162847 | 48780-1 | f386c64a-0c8b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS. BUPROPION hydrochloride extended-release tablets, for oral use Initial U.S. Approval: 1985 |
| 50090-4747-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0c8b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS. BUPROPION hydrochloride extended-release tablets, for oral use Initial U.S. Approval: 1985 |
| 50090-4747-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0c8b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS. BUPROPION hydrochloride extended-release tablets, for oral use Initial U.S. Approval: 1985 |
| 50090-4747-2 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0c8b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS. 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 |
|---|
| 50090-4747-0 | Bupropion Hydrochloride | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 9 |
| 50090-4747-1 | Bupropion Hydrochloride | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 9 |
| 50090-4747-2 | Bupropion Hydrochloride | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-4747 | BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS] | 7 | Current NDC, Legacy NDC, 3 package rows | 20250131_6902b252-dc69-4b3c-bad2-b6667a5f6d84.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 |
|---|
| 50090-4747-0 | 50090474700 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4747-0) | 2019-11-22 | 0000-00-00 | No | No | Current |
| 50090-4747-1 | 50090474701 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4747-1) | 2019-11-22 | 0000-00-00 | No | No | Current |
| 50090-4747-2 | 50090474702 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4747-2) | 2019-11-22 | 0000-00-00 | No | No | Current |