Evekeo ODT

Product NDC
24338-031
11-digit product format
243380031
Labeler code
24338
Product ID
24338-031_84fe08cc-dddd-4ab6-9d7a-f62076b924e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMPHETAMINE SULFATE
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Azurity Pharmaceuticals, Inc.
Application
NDA209905
Marketing category
NDA
Marketing start
2019-06-28
Marketing end
0000-00-00
Substance
AMPHETAMINE 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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24338-031-01EA - Each24338-031f377abd2-2795-4d9a-a54f-7121086665fa12019-07-02
24338-031-30EA - Each24338-031a7ea792f-100a-4cb3-b1f3-b9c8b553492712019-07-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24338-031-01243380031011 CASE in 1 CARTON (24338-031-01) > 1 BLISTER PACK in 1 CASE (24338-031-30) > 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 case2019-06-280000-00-00NoNoCurrent