Bupropion Hydrochloride
- Product NDC
- 0615-8504
- 11-digit product format
- 006158504
- Labeler code
- 0615
- Product ID
- 0615-8504_31890576-e68d-4449-b0dd-205175720f6b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA211020
- Marketing category
- ANDA
- Marketing start
- 2022-08-01
- 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 |
|---|
| 0615-8504-05 | 00615850405 | 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8504-05) | 2024-07-16 | No | No | Historical |
| 0615-8504-39 | 00615850439 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8504-39) | 2024-03-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Bupropion Hydrochloride | NCS HealthCare of KY, LLC dba Vangard Labs | 2024-08-12 | HUMAN PRESCRIPTION DRUG LABEL | 2 |