| NDC Code | 57664-953-88 |
| Package Description | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (57664-953-88) |
| Product NDC | 57664-953 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate |
| Non-Proprietary Name | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate |
| Dosage Form | CAPSULE, EXTENDED RELEASE |
| Usage | ORAL |
| Start Marketing Date | 20240201 |
| Marketing Category Name | ANDA |
| Application Number | ANDA215997 |
| Manufacturer | Sun Pharmaceutical Industries, Inc. |
| Substance Name | AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
| Strength | 12.5; 12.5; 12.5; 12.5 |
| Strength Unit | mg/1; mg/1; mg/1; mg/1 |
| Pharmacy Classes | Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE] |
| DEA Schedule | CII |