Bupropion hydrochloride
- Product NDC
- 71335-2400
- 11-digit product format
- 713352400
- Labeler code
- 71335
- Product ID
- 71335-2400_38984dde-4201-4bd1-9a7c-44537f91be8c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA216800
- Marketing category
- ANDA
- Marketing start
- 2023-05-31
- Substance
- BUPROPION HYDROCHLORIDE
- Active strength
- 200 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
- 71335-2400_38984dde-4201-4bd1-9a7c-44537f91be8c
- 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
- 2023-05-31
- Marketing category
- ANDA
- Application number
- ANDA216800
- 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 | 200 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | ZG7E5POY8O |
| Rxcui | 993536 |
| Spl Set Id | 5c111cf0-0199-4a4d-8138-81579af4c14d |
| 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 |
|---|
| 71335-2400-1 | 71335240001 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2400-1) | 2024-06-13 | No | No | Current |
| 71335-2400-2 | 71335240002 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2400-2) | 2024-06-13 | No | No | Current |
| 71335-2400-3 | 71335240003 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2400-3) | 2024-06-13 | No | No | Current |
| 71335-2400-4 | 71335240004 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2400-4) | 2024-06-13 | No | No | Current |
| 71335-2400-5 | 71335240005 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2400-5) | 2024-06-13 | No | No | Current |
| 71335-2400-6 | 71335240006 | 28 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2400-6) | 2024-06-13 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Bupropion hydrochloride | Bryant Ranch Prepack | 2025-03-31 | HUMAN PRESCRIPTION DRUG LABEL | 2 |