Quick answers
- What is Dexedrine Spansule?
- Dexedrine Spansule is a brand name of Dextroamphetamine, a prescription medicine. The FDA NDC Directory lists 3 Dexedrine Spansule products in 3 strengths and forms.
- Who makes Dexedrine Spansule?
- Impax Labs Inc holds the FDA application for Dexedrine Spansule (NDA017078, approved August 2, 1976).
- Is there a generic or store brand of Dexedrine Spansule?
- Yes. The FDA NDC Directory lists 9 other products with the same active ingredients, strength and form as a Dexedrine Spansule product, 9 of them generic. Ask your pharmacist whether one is right for you.
- Has Dexedrine Spansule been recalled?
- No recall linked to Dexedrine Spansule products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Dexedrine Spansule is
Each Dexedrine Spansule product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Dextroamphetamine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| dextroamphetamine sulfate 10 mg capsule, extended release (oral) | Dexedrine Spansule | 3 products, 3 companies | DailyMed |
| dextroamphetamine sulfate 15 mg capsule, extended release (oral) | Dexedrine Spansule | 3 products, 3 companies | DailyMed |
| dextroamphetamine sulfate 5 mg capsule, extended release (oral) | Dexedrine Spansule | 3 products, 3 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Dextroamphetamine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA017078 | Impax Labs Inc | August 2, 1976 | 3 |
Companies that list Dexedrine Spansule
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Dexedrine Spansule products.
- Amneal Pharmaceuticals LLC3 products
Recalls
No recall linked to Dexedrine Spansule products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.