Bupropion Hydrochloride
- Product NDC
- 71335-2378
- 11-digit product format
- 713352378
- Labeler code
- 71335
- Product ID
- 71335-2378_d9807f26-dfac-45a6-8279-83c1f54a113e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupropion hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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
openFDA Listing Details
- Product ID
- 71335-2378_d9807f26-dfac-45a6-8279-83c1f54a113e
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Bupropion Hydrochloride
- Brand name suffix
- XL
- Generic name
- bupropion hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing start
- 2023-04-30
- Marketing category
- ANDA
- Application number
- ANDA210015
- Pharmacologic classes
- Aminoketone [EPC]; Dopamine Uptake Inhibitors [MoA]; Increased Dopamine Activity [PE]; Increased Norepinephrine Activity [PE]; Norepinephrine Uptake Inhibitors [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| BUPROPION HYDROCHLORIDE | 150 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | ZG7E5POY8O |
| Rxcui | 993541 |
| Spl Set Id | eb25adb1-9841-42ce-aa22-718fb0fba5dd |
| Manufacturer Name | Bryant Ranch Prepack |
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 |
|---|
| 71335-2378-1 | 71335237801 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2378-1) | 2024-04-16 | No | No | Current |
| 71335-2378-2 | 71335237802 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2378-2) | 2024-06-12 | No | No | Current |
| 71335-2378-3 | 71335237803 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2378-3) | 2024-03-27 | No | No | Current |
| 71335-2378-4 | 71335237804 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2378-4) | 2025-01-31 | No | No | Current |
| 71335-2378-5 | 71335237805 | 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2378-5) | 2025-01-31 | No | No | Current |