Methylphenidate Hydrochloride

Product NDC
16714-127
11-digit product format
167140127
Labeler code
16714
Product ID
16714-127_0708b572-6b5d-4f9e-9183-1b694e6ac44f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Northstar Rx LLC
Application
ANDA211009
Marketing category
ANDA
Marketing start
2019-10-09
Marketing end
0000-00-00
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
54 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-127-01EA - Each16714-127f451fa62-f3f5-487a-8c22-4215d4d8a06c12020-01-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-127-0116714012701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-127-01) 2019-10-090000-00-00NoNoCurrent