dextroamphetamine sulfate

Product NDC
51862-344
11-digit product format
518620344
Labeler code
51862
Product ID
51862-344_348dccbd-c876-417c-a849-0059aec5516c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dextroamphetamine sulfate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Mayne Pharma Inc.
Application
ANDA203901
Marketing category
ANDA
Marketing start
2016-08-05
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51862-344-90EA - Each51862-344371c062f-95a1-4e5b-bd45-2ddfc367948e12016-09-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51862-344-905186203449090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51862-344-90) 2016-08-050000-00-00NoNoCurrent