Drug shortages

Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet

Elite Laboratories, Inc. · Available

Current64850-504-01Psychiatry
Open FDA's page for this record
Update type
Reverified
Initial posting date
10/12/2022
Package NDC
64850-504-01
Generic name
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet
Contact info
888-852-6657
Availability
Available
Update date
09/16/2026
Dosage form
Tablet
Company name
Elite Laboratories, Inc.
Status
Current
Presentation

Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg (NDC 64850-504-01)

Therapeutic category
Psychiatry
Harmonized identifiers (openFDA)
Application number
ANDA211352
Brand name
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Generic name
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Manufacturer name
Elite Laboratories, Inc.
Product NDC
64850-504, 64850-500, 64850-501, 64850-502, 64850-503, 64850-505, 64850-506
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE
RxCUI
541363, 541878, 541892, 577957, 577961, 687043, 1009145
SPL ID
a41cf8e5-cb1b-488c-96b3-3bef8283d6c4
SPL set ID
e677690f-790f-4626-ad78-097cdb6ea540
Package NDC
64850-500-01, 64850-500-05, 64850-500-30, 64850-501-01, 64850-501-05, 64850-501-30, 64850-502-01, 64850-502-05, 64850-502-30, 64850-503-01, 64850-503-05, 64850-503-30, 64850-504-01, 64850-504-05, 64850-504-30, 64850-505-01, 64850-505-05, 64850-505-30, 64850-506-01, 64850-506-05, 64850-506-30
UNII
6DPV8NK46S, G83415V073, O1ZPV620O4, JJ768O327N
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.