Bupropion Hydrochloride
- Product NDC
- 76420-812
- 11-digit product format
- 764200812
- Labeler code
- 76420
- Product ID
- 76420-812_2dffd9ed-8b4a-a56b-e063-6394a90ae043
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA077285
- Marketing category
- ANDA
- Marketing start
- 2015-02-17
- Substance
- BUPROPION HYDROCHLORIDE
- Active strength
- 300 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 |
|---|
| 76420-812-01 | 76420081201 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-01) | 2024-05-07 | No | No | Historical |
| 76420-812-05 | 76420081205 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-05) | 2024-05-07 | No | No | Historical |
| 76420-812-30 | 76420081230 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-30) | 2024-05-07 | No | No | Historical |
| 76420-812-60 | 76420081260 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-60) | 2024-05-07 | No | No | Historical |
| 76420-812-90 | 76420081290 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-90) | 2024-05-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Bupropion Hydrochloride | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2025-02-12 | HUMAN PRESCRIPTION DRUG LABEL | 2 |