Bupropion Hydrochloride
- Product NDC
- 82804-080
- 11-digit product format
- 828040080
- Labeler code
- 82804
- Product ID
- 82804-080_dfd5f264-d4fd-4441-88b1-48086c7c0616
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupropion hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA210015
- Marketing category
- ANDA
- Marketing start
- 2023-04-30
- 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
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Bupropion Hydrochloride
- Brand name suffix
- XL
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| BUPROPION HYDROCHLORIDE | 150 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | ZG7E5POY8O |
| Rxcui | 993541 |
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 |
|---|
| 82804-080-30 | 82804008030 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-080-30) | 2024-03-05 | No | No | Historical |
| 82804-080-60 | 82804008060 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-080-60) | 2024-03-05 | No | No | Historical |
| 82804-080-90 | 82804008090 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-080-90) | 2024-03-05 | No | No | Historical |