NDC 35573-469
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate 4 ingredients capsule, extended release
On the label: Burel Pharmaceuticals, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Elite Laboratories, Inc. | Northvale, NJ, United States | Makes it and labels it | Problems found, fixed voluntarilyAug 1, 2025 · 12 inspections, 1 with FDA action |
Product details
- Generic drug
- Amphetamine and Dextroamphetamine: every company that makes it
- Form
- capsule, extended release, oral
- Strength
- 4 ingredients
- Approval
- ANDA ANDA212037
- On the market since
- Dec 16, 2019
- Package NDCs
35573-469-02- Official label
- DailyMed (National Library of Medicine), updated Dec 16, 2025
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