QuilliChew ER

Product NDC
24478-140
11-digit product format
244780140
Labeler code
24478
Product ID
24478-140_25328c32-7c32-4809-b38c-e8db1756e8a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylphenidate hydrochloride
Dosage form
TABLET, CHEWABLE, EXTENDED RELEASE
Route
ORAL
Labeler
NextWave Pharmaceuticals, Inc.
Application
NDA207960
Marketing category
NDA
Marketing start
2016-04-18
Marketing end
0000-00-00
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24478-140-01EA - Each24478-140a9d5c43e-afc6-4ca1-b584-a76d2f48ce0812016-02-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24478-140-0124478014001100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-140-01) 2016-04-180000-00-00NoNoCurrent