NDC Code | 54868-5140-0 |
Package Description | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54868-5140-0) |
Product NDC | 54868-5140 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Adderall |
Proprietary Name Suffix | Xr |
Non-Proprietary Name | Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate |
Dosage Form | CAPSULE, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20040816 |
Marketing Category Name | NDA |
Application Number | NDA021303 |
Manufacturer | Physicians Total Care, Inc. |
Substance Name | DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE |
Strength | 3.75; 3.75; 3.75; 3.75 |
Strength Unit | mg/1; mg/1; mg/1; mg/1 |
Pharmacy Classes | Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |
DEA Schedule | CII |