Bupropion Hydrochloride
- Product NDC
- 68788-7988
- 11-digit product format
- 687887988
- Labeler code
- 68788
- Product ID
- 68788-7988_c315824b-c5d7-4e7a-942b-1c502c05bbbd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA076143
- Marketing category
- ANDA
- Marketing start
- 2021-08-06
- Substance
- BUPROPION HYDROCHLORIDE
- Active strength
- 100 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
- 2027-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 68788-7988_c315824b-c5d7-4e7a-942b-1c502c05bbbd
- SPL ID
- c315824b-c5d7-4e7a-942b-1c502c05bbbd
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Bupropion Hydrochloride
- Generic name
- Bupropion Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2021-08-06
- Marketing category
- ANDA
- Application number
- ANDA076143
- Pharmacologic classes
- Aminoketone [EPC]; Dopamine Uptake Inhibitors [MoA]; Increased Dopamine Activity [PE]; Increased Norepinephrine Activity [PE]; Norepinephrine Uptake Inhibitors [MoA]
- Listing expiration
- 2027-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| BUPROPION HYDROCHLORIDE | 100 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | ZG7E5POY8O |
| Rxcui | 993687 |
| Spl Set Id | eabb54b7-164c-4de8-b91a-f2e65637b5fc |
| Manufacturer Name | Preferred Pharmaceuticals Inc. |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 68788-7988-1 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-7988-1) | 2024-03-11 | No |
| 68788-7988-3 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-7988-3) | 2021-08-06 | No |
| 68788-7988-6 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-7988-6) | 2021-08-06 | No |
| 68788-7988-9 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-7988-9) | 2021-08-06 | No |
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 |
|---|
| 68788-7988-1 | 68788798801 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-7988-1) | 2024-03-11 | No | No | Historical |
| 68788-7988-3 | 68788798803 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-7988-3) | 2021-08-06 | No | No | Historical |
| 68788-7988-6 | 68788798806 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-7988-6) | 2021-08-06 | No | No | Historical |
| 68788-7988-9 | 68788798809 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-7988-9) | 2021-08-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Bupropion Hydrochloride | Preferred Pharmaceuticals Inc. | 2026-03-20 | HUMAN PRESCRIPTION DRUG LABEL | 7 |