Dextroamphetamine SulfateExtended-Release

Product NDC
0115-1703
11-digit product format
001151703
Labeler code
0115
Product ID
0115-1703_27072364-bca1-4260-bffe-29e409573f4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextroamphetamine Sulfate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
NDA017078
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1976-08-02
Marketing end
0000-00-00
Substance
DEXTROAMPHETAMINE SULFATE
Active strength
10 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
0115-1703-10EA - Each0115-1703edb6734e-515e-4ceb-990e-33e748f0dd6412018-03-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0115-1703-100011517031090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1703-10) 1976-08-020000-00-00NoNoCurrent