Central Nervous System Stimulant
Where is Dextroamphetamine made?
18 companies sell it under their own name and 2 repackagers rebottle it. Their labels name 10 factories in the United States.
United States 10
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals Dexedrinespansule5 mg, 10 mg, 15 mg · NDC 0115-9928, 64896-674, 0115-9929 +3 | Cambrex Charles City, IncMakes the active ingredient | Charles City, IA, United States | Problems found, fixed voluntarilyMar 2025 |
| Catalent Pharma Solutions, LLCMakes it and tests it | Winchester, KY, United States | Problems found, fixed voluntarilyApr 2025 | |
| SpecGx LLC5 mg, 10 mg, 15 mg · NDC 0406-8959, 0406-8961, 0406-8962 +2 | SpecGx LLCMakes it and tests it | Hobart, NY, United States | No problems foundMar 2020 |
| SpecGx LLCMakes the active ingredient | St. Louis, MO, United States | Problems found, fixed voluntarilyOct 2025 | |
| Aurolife Pharma LLC5 mg, 10 mg · NDC 13107-036, 13107-035 | Aurolife Pharma LLCMakes it | Dayton, NJ, United States | Serious problems, FDA actionDec 2021 |
| Cranbury Pharmaceuticals, LLC5 mg, 5 mg per 5 mL, 10 mg · NDC 27808-090, 27808-089, 27808-085 | Tris Pharma IncMakes it | Monmouth Junction, NJ, United States | Problems found, fixed voluntarilyNov 2025 |
| KVK-TECH, Inc.5 mg, 10 mg · NDC 10702-066, 10702-065 | Kvk-Tech, Inc.Makes it | Newtown, PA, United States | Serious problems, FDA actionMar 2025 |
| Lupin Pharmaceuticals, Inc.5 mg, 10 mg · NDC 43386-871, 43386-870 | Novel Laboratories, Inc.Makes it and tests it | Somerset, NJ, United States | Problems found, fixed voluntarilyApr 2026 |
| Novel Laboratories, Inc.5 mg, 10 mg · NDC 40032-871, 40032-870 | Novel Laboratories, Inc.Makes it, tests it and packages it | Somerset, NJ, United States | Problems found, fixed voluntarilyApr 2026 |
| Noven Therapeutics, LLC Xelstrym4.5 mg, 9 mg, 13.5 mg, 18 mg · NDC 68968-0215, 68968-0220, 68968-0205 +1 | Noven Pharmaceuticals, Inc.Makes it, tests it, packages it and labels it | Miami, FL, United States | Problems found, fixed voluntarilyAug 2026 |
| Sunrise Pharmaceutical, Inc.5 mg, 10 mg · NDC 11534-189, 11534-188 | Sunrise Pharmaceutical IncMakes it | Rahway, NJ, United States | Problems found, fixed voluntarilyMar 2026 |
| Zydus Pharmaceuticals (USA) Inc.5 mg, 10 mg, 15 mg · NDC 68382-942, 68382-944, 68382-945 +2 | Nesher Pharmaceuticals (USA) LLCMakes it and tests it | Location not on file | Not inspected on record |
| Actavis Pharma, Inc.5 mg, 10 mg, 15 mg · NDC 45963-304, 45963-305, 45963-303 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg · NDC 24338-853, 24338-854, 24338-850 +4 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Ethex Corporation5 mg, 10 mg · NDC 58177-312, 58177-311 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Independence Pharmaceuticals, LLC5 mg per 5 mL · NDC 21724-701 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Prasco Laboratories5 mg per 5 mL · NDC 66993-359 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.5 mg, 10 mg · NDC 0555-0953, 0555-0952 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Wilshire Pharmaceuticals Inc.5 mg, 10 mg, 15 mg, 20 mg, 30 mg · NDC 52536-510, 52536-515, 52536-520 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Winder Laboratories, LLC2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg · NDC 75826-123, 75826-124, 75826-120 +4 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Dextroamphetamine in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- Bryant Ranch Prepack:
72162-1234,72162-2350,63629-2374,72162-2351+6 - Physicians Total Care, Inc.:
54868-5479,54868-5388
Recalls
- Oct 31, 2024 · Class II · Noven Pharmaceuticals Inc
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive). - Jan 4, 2024 · Class I · Azurity Pharmaceuticals, Inc.
Labeling: Label Mix-up - Jul 11, 2016 · Class II · Actavis Inc
Failed Dissolution Specifications - Feb 10, 2015 · Class II · Actavis Elizabeth LLC
Failed Dissolution Specifications - May 1, 2014 · Class II · Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.