Methylphenidate Hydrochloride

Product NDC
0527-1915
11-digit product format
005271915
Labeler code
0527
Product ID
0527-1915_708f490c-fde3-4c6d-9c0c-a52d6d5160e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA207414
Marketing category
ANDA
Marketing start
2020-12-16
Marketing end
0000-00-00
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
10 mg/5mL
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1915-6500527191565500 mL in 1 BOTTLE (0527-1915-65) 500 ml2020-12-160000-00-00NoNoCurrent