NDC 0378-8263

Methylphenidate

Methylphenidate

Methylphenidate is a Transdermal Patch in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Methylphenidate.

Product ID0378-8263_1643b6a5-80da-4d4f-8c5f-feb907875702
NDC0378-8263
Product TypeHuman Prescription Drug
Proprietary NameMethylphenidate
Generic NameMethylphenidate
Dosage FormPatch
Route of AdministrationTRANSDERMAL
Marketing Start Date2022-06-27
Marketing CategoryANDA /
Application NumberANDA206497
Labeler NameMylan Pharmaceuticals Inc.
Substance NameMETHYLPHENIDATE
Active Ingredient Strength3 mg/h
Pharm ClassesCentral Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0378-8263-93

30 POUCH in 1 CARTON (0378-8263-93) > 1 PATCH in 1 POUCH (0378-8263-16) > 9 h in 1 PATCH
Marketing Start Date2022-06-27
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Methylphenidate" or generic name "Methylphenidate"

NDCBrand NameGeneric Name
0378-8260MethylphenidateMethylphenidate
0378-8261MethylphenidateMethylphenidate
0378-8262MethylphenidateMethylphenidate
0378-8263MethylphenidateMethylphenidate
0781-2361Methylphenidatemethylphenidate
0781-2362Methylphenidatemethylphenidate
0781-2363Methylphenidatemethylphenidate
0781-2364Methylphenidatemethylphenidate
10702-163MethylphenidateMethylphenidate Hydrochloride
10702-164MethylphenidateMethylphenidate Hydrochloride
68968-5552Daytranamethylphenidate
68968-5553Daytranamethylphenidate
68968-5554Daytranamethylphenidate
68968-5555Daytranamethylphenidate

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