Drug
Who makes amphetamine?
4 companies list amphetamine as a human prescription drug, including under the names Adzenys XR-ODT, Dyanavel XR. Forms: suspension, extended release; tablet; tablet, extended release; tablet, orally disintegrating. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing amphetamine
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Teva Pharmaceutical Industries Ltd.Canada | tablet, orally disintegrating | ANDAANDA209253 | 6 | 6 |
| Neos Therapeutics Brands, LLC | tablet, orally disintegrating | NDANDA204326 | 6 | 0 |
| NextWave Pharmaceuticals, Inc | suspension, extended release; tablet, extended release | NDANDA208147, NDA210526 | 5 | 0 |
| Amneal Pharmaceuticals NY LLC | tablet | ANDAANDA211139 | 2 | 0 |
Orange Book patents
4 unexpired patents list amphetamine as the active ingredient, expiring between Jun 2032 and Jun 2032. Application holders: NEOS THERAPEUTICS, NEOS THERAPEUTICS INC.
Enquiry
Common questions
- Who makes amphetamine?
- 4 companies list amphetamine as a human prescription drug in the openFDA NDC Directory, led by Teva Pharmaceutical Industries Ltd., Neos Therapeutics Brands, LLC, NextWave Pharmaceuticals, Inc, Amneal Pharmaceuticals NY LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Adzenys XR-ODT?
- 2 companies list amphetamine under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.