Quillivant

Product NDC
24478-190
11-digit product format
244780190
Labeler code
24478
Product ID
24478-190_3c243fb6-41ad-44b8-a644-1d5a9d3df322
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylphenidate hydrochloride
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
NextWave Pharmaceuticals, Inc
Application
NDA202100
Marketing category
NDA
Marketing start
2012-10-01
Marketing end
0000-00-00
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
300 mg/60mL
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
24478-190-10ML - Milliliter24478-1902816e958-27ba-45c2-ae64-2492968d222c12013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24478-190-10244780190101 BOTTLE in 1 CARTON (24478-190-10) > 60 mL in 1 BOTTLE1 bottle2012-10-010000-00-00NoNoCurrent