NDC 70010-033
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate 4 ingredients capsule, extended release
On the label: Granules Pharmaceuticals Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Granules Pharmaceuticals Inc. | Chantilly, VA, United States | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyApr 3, 2026 · 6 inspections |
Recalls
- Aug 28, 2025 · Class III · Granules Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications:
Lots: Lot#: GPC250158A, Exp Date: 06-22-2027 - Aug 28, 2025 · Class III · Granules Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications:
Lots: lot#: GPC250159A, Exp Date: 06-22-2027 - Aug 28, 2025 · Class III · Granules Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications:
Lots: Lot#: GPC250178A, Exp Date: 06-22-2027 - Aug 28, 2025 · Class III · Granules Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications:
Lots: Lot#: GPC250179A, Exp Date: 06-22-2027 - Aug 28, 2025 · Class III · Granules Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications:
Lots: Lot#: GPC250181A, Exp Date: 06-19-2027
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Amphetamine and Dextroamphetamine: every company that makes it
- Form
- capsule, extended release, oral
- Strength
- 4 ingredients
- Approval
- ANDA ANDA217027
- On the market since
- Feb 20, 2023
- Package NDCs
70010-033-01- Official label
- DailyMed (National Library of Medicine), updated May 13, 2026
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