Bupropion hydrochloride
- Product NDC
- 80425-0300
- 11-digit product format
- 804250300
- Labeler code
- 80425
- Product ID
- 80425-0300_2a9bf621-afbc-7627-e063-6294a90a77a9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA210497
- Marketing category
- ANDA
- Marketing start
- 2023-04-06
- 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
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| ZG7E5POY8O | BUPROPION HYDROCHLORIDE | 31677-93-7 | BUPROPION HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0300-1 | 80425030001 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0300-1) | 2023-04-06 | No | No | Historical |
| 80425-0300-2 | 80425030002 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0300-2) | 2023-04-06 | No | No | Historical |
| 80425-0300-3 | 80425030003 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0300-3) | 2023-04-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Bupropion HCL ER Tablets | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 2 |