Methylphenidate Hydrochloride

Product NDC
0093-5297
11-digit product format
000935297
Labeler code
0093
Product ID
0093-5297_cdbc33ef-8684-42b1-81bf-3e61b299f174
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA077707
Marketing category
ANDA
Marketing start
2012-09-27
Marketing end
0000-00-00
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5297-01EA - Each0093-5297b16a94ed-5a45-4172-a515-80a08debcee712013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-5297-0100093529701100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5297-01) 2012-09-270000-00-00NoNoCurrent