Quillivant

Product NDC
24478-200
11-digit product format
244780200
Labeler code
24478
Product ID
24478-200_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
600 mg/120mL
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
24478-200-20ML - Milliliter24478-2002ffe34b8-d9fb-4de6-9430-9732ab4cb4e012013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24478-200-20244780200201 BOTTLE in 1 CARTON (24478-200-20) > 120 mL in 1 BOTTLE1 bottle2012-10-010000-00-00NoNoCurrent