FDA NDC Directory · JSON-LD · Markdown

Mixed Salts of a Single-Entity Amphetamine Product

NDC 0406-0803 · HUMAN PRESCRIPTION DRUG · CAPSULE, EXTENDED RELEASE

Generic nameDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE
Labeler / ManufacturerSpecGx LLC
Marketing categoryAbbreviated NDA (generic) · App ANDA211546
Dosage form / routeCAPSULE, EXTENDED RELEASE · ORAL
Active ingredientsAMPHETAMINE ASPARTATE MONOHYDRATE (6.25 mg/1)
AMPHETAMINE SULFATE (6.25 mg/1)
DEXTROAMPHETAMINE SACCHARATE (6.25 mg/1)
DEXTROAMPHETAMINE SULFATE (6.25 mg/1)
Marketing started20231101
Package count1

External sources

Source: openFDA. Public-domain (CC0).