Dextroamphetamine Sulfate

Product NDC

54505-327

11-digit product format

545050327

Labeler code

54505

Product ID

54505-327_06a03f71-57f1-4a7b-99d0-0a416d0bdacc

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Dextroamphetamine Sulfate

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Labeler

Lineage Therapeutics Inc

Application

NDA017078

Marketing category

NDA AUTHORIZED GENERIC

Marketing start

1976-08-02

Marketing end

2019-11-01

Substance

DEXTROAMPHETAMINE SULFATE

Active strength

5 mg/1

Pharmacologic classes

Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]

DEA schedule

CII

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record