Bupropion hydrochloride
- Product NDC
- 71335-2499
- 11-digit product format
- 713352499
- Labeler code
- 71335
- Product ID
- 71335-2499_28a2d1e3-d88b-4312-99a9-54592acd5a27
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA215568
- Marketing category
- ANDA
- Marketing start
- 2022-12-15
- 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
openFDA Listing Details
- Product ID
- 71335-2499_28a2d1e3-d88b-4312-99a9-54592acd5a27
- SPL ID
- 28a2d1e3-d88b-4312-99a9-54592acd5a27
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Bupropion hydrochloride
- Generic name
- Bupropion hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing start
- 2022-12-15
- Marketing category
- ANDA
- Application number
- ANDA215568
- 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 | 300 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | ZG7E5POY8O |
| Rxcui | 993557 |
| Spl Set Id | bf5e933c-8a84-4dd7-a05d-6c4a82b6c965 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-2499-1 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2499-1) | 2024-09-23 | No |
| 71335-2499-2 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2499-2) | 2024-09-23 | No |
| 71335-2499-3 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2499-3) | 2024-09-23 | No |
| 71335-2499-4 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2499-4) | 2024-09-23 | No |
| 71335-2499-5 | 8 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2499-5) | 2024-09-23 | No |
| 71335-2499-6 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2499-6) | 2024-09-23 | 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 |
|---|
| 71335-2499-1 | 71335249901 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2499-1) | 2024-09-23 | No | No | Historical |
| 71335-2499-2 | 71335249902 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2499-2) | 2024-09-23 | No | No | Historical |
| 71335-2499-3 | 71335249903 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2499-3) | 2024-09-23 | No | No | Historical |
| 71335-2499-4 | 71335249904 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2499-4) | 2024-09-23 | No | No | Historical |
| 71335-2499-5 | 71335249905 | 8 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2499-5) | 2024-09-23 | No | No | Historical |
| 71335-2499-6 | 71335249906 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2499-6) | 2024-09-23 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Bupropion hydrochloride | Bryant Ranch Prepack | 2024-09-23 | HUMAN PRESCRIPTION DRUG LABEL | 2 |