NDC product
Mixed Salts of a Single Entity Amphetamine Product XR
NDC 0406-8952 · SpecGx LLC
Key facts
| Product NDC | 0406-8952 |
|---|---|
| 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 | ANDA211547 |
| DEA schedule | CII |
| Pharmacologic classes | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
| Marketing start | Apr 22, 2019 |
| Listing certified through | Dec 31, 2026 |
At a glance
- 1–9 Package NDCs
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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: