# Mixed Salts of a Single-Entity Amphetamine Product

NDC: 0406-0803
Generic name: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE
Labeler / Manufacturer: SpecGx LLC
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: CAPSULE, EXTENDED RELEASE
Routes: ORAL
Marketing started: 20231101

FDA application: ANDA211546

## Active ingredients

- AMPHETAMINE ASPARTATE MONOHYDRATE: 6.25 mg/1
- AMPHETAMINE SULFATE: 6.25 mg/1
- DEXTROAMPHETAMINE SACCHARATE: 6.25 mg/1
- DEXTROAMPHETAMINE SULFATE: 6.25 mg/1

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"0406-0803"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=0406-0803
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78