Bupropion Hydrochloride
- Product NDC
- 85534-0006
- 11-digit product format
- 855340006
- Labeler code
- 85534
- Product ID
- 85534-0006_3745abec-26fc-d50e-e063-6294a90a037d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- HAWAII REPACK, 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 |
|---|
| 85534-0006-1 | 85534000601 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (85534-0006-1) | 2025-06-11 | No | No | Historical |
| 85534-0006-3 | 85534000603 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (85534-0006-3) | 2025-06-11 | No | No | Historical |
| 85534-0006-5 | 85534000605 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (85534-0006-5) | 2025-06-11 | No | No | Historical |
| 85534-0006-6 | 85534000606 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (85534-0006-6) | 2025-06-11 | No | No | Historical |
| 85534-0006-9 | 85534000609 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (85534-0006-9) | 2025-06-11 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Bupropion Hydrochloride | HAWAII REPACK, INC. | 2025-06-11 | HUMAN PRESCRIPTION DRUG LABEL | 1 |