Bupropion Hydrochloride
- Product NDC
- 63629-8475
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupropion hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA207479
- Marketing category
- ANDA
- Substance
- BUPROPION HYDROCHLORIDE
- Current FDA listing
- Yes
Related Records
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|---|---|---|---|---|
| 63629-8475-1 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-8475-1) | 2017-04-12 | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|---|---|---|---|
| These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE extended-release tablets (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE extended-release tablets (XL). BUPROPION HYDROCHLORIDE extended-release tablets (XL), for oral use Initial U.S. Approval: 1985 | Bryant Ranch Prepack | 2026-04-08 | HUMAN PRESCRIPTION DRUG LABEL | 104 |