NDC product
Mixed Salts of a Single-Entity Amphetamine Product
NDC 0406-0807 · SpecGx LLC
Key facts
| Product NDC | 0406-0807 |
|---|---|
| Proprietary name | Mixed Salts of a Single-Entity Amphetamine Product |
| Nonproprietary name | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE |
| Substances | DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE |
| Dosage form | CAPSULE, EXTENDED RELEASE |
| Route | ORAL |
| Labeler | SpecGx LLC |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Application number | ANDA211546 |
| DEA schedule | CII |
| Pharmacologic classes | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
| Marketing start | Nov 1, 2023 |
| Listing certified through | Dec 31, 2026 |
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 · Source date: