ADHANSIA XR

Product NDC
72912-545
11-digit product format
729120545
Labeler code
72912
Product ID
72912-545_d5202e47-4f6c-423a-8f94-a8a5402da896
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylphenidate hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Adlon Therapeutics L.P.
Application
NDA212038
Marketing category
NDA
Marketing start
2019-07-01
Marketing end
2023-11-01
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
45 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72912-545-30EA - Each72912-54518369a1c-1ae4-4640-bdf1-e91d7d6701a412019-07-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72912-545-307291205453030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72912-545-30) 2019-07-010000-00-00NoNoCurrent