Bupropion hydrochloride
- Product NDC
- 68788-8815
- 11-digit product format
- 687888815
- Labeler code
- 68788
- Product ID
- 68788-8815_1724f474-d6ab-46af-940f-7f874d4ff7fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA215568
- Marketing category
- ANDA
- Marketing start
- 2025-01-21
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bupropion hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPROPION HYDROCHLORIDE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ZG7E5POY8O |
| Rxcui | 993557 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8815-1 | 68788881501 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8815-1) | 2025-01-21 | No | No | Historical |
| 68788-8815-3 | 68788881503 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8815-3) | 2025-01-21 | No | No | Historical |
| 68788-8815-6 | 68788881506 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8815-6) | 2025-01-21 | No | No | Historical |
| 68788-8815-8 | 68788881508 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8815-8) | 2025-01-21 | No | No | Historical |
| 68788-8815-9 | 68788881509 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8815-9) | 2025-01-21 | No | No | Historical |