METHYLPHENIDATE HYDROCHLORIDE

Product NDC
69452-166
11-digit product format
694520166
Labeler code
69452
Product ID
69452-166_b2315c5a-d4ef-40aa-e053-2995a90a17ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHYLPHENIDATE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA209753
Marketing category
ANDA
Marketing start
2018-03-21
Marketing end
2021-03-31
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
10 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-166-20EA - Each69452-166322e2fe3-84bb-4ff9-94e3-04864067fcfb12019-03-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-166-2069452016620100 TABLET in 1 BOTTLE (69452-166-20) 100 tablet2018-03-212021-03-31NoNoCurrent