NDC product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate
NDC 35573-469 · Burel Pharmaceuticals, LLC
Key facts
| Product NDC | 35573-469 |
|---|---|
| Proprietary name | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
| Nonproprietary name | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
| Substances | DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE |
| Dosage form | CAPSULE, EXTENDED RELEASE |
| Route | ORAL |
| Labeler | Burel Pharmaceuticals, LLC |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Application number | ANDA212037 |
| DEA schedule | CII |
| Pharmacologic classes | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
| Marketing start | Dec 16, 2019 |
| Marketing end | Feb 29, 2028 |
At a glance
- 1–9 Package NDCs
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About National Drug Codes (NDC)
The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.
Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory