Methylphenidate Hydrochloride
- Product NDC
- 42858-076
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylphenidate Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Rhodes Pharmaceuticals
- Application
- NDA205831
- Marketing category
- NDA AUTHORIZED GENERIC
- Substance
- METHYLPHENIDATE HYDROCHLORIDE
- Current FDA listing
- Yes
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|
| 42858-076-45 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-076-45) | 20200401 | | No | Historical |
Related DailyMed Labels
| Set ID | Title | Manufacturer | Effective date | Type | Version |
|---|
| f7a7ffd1-bc30-4db8-8391-dddf76acd639 | These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Capsules safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Capsules Methylphenidate Hydrochloride Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 1955 | Rhodes Pharmaceuticals | Patheon Manufacturing Services LLC | Purdue Pharmaceuticals L.P. | 2025-10-01 | HUMAN PRESCRIPTION DRUG LABEL | 7 |