DEXEDRINE

Product NDC

52054-512

11-digit product format

520540512

Labeler code

52054

Product ID

52054-512_6e6c242b-da63-4bd3-86a6-f22e10419291

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

dextroamphetamine sulfate

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Labeler

Amedra Pharmaceuticals LLC

Application

NDA017078

Marketing category

NDA

Marketing start

1976-08-02

Marketing end

2019-12-01

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