NDC 16714-124

Methylphenidate Hydrochloride

Methylphenidate Hydrochloride

Methylphenidate Hydrochloride is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Northstar Rx Llc. The primary component is Methylphenidate Hydrochloride.

Product ID16714-124_0708b572-6b5d-4f9e-9183-1b694e6ac44f
NDC16714-124
Product TypeHuman Prescription Drug
Proprietary NameMethylphenidate Hydrochloride
Generic NameMethylphenidate Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-10-09
Marketing CategoryANDA / ANDA
Application NumberANDA211009
Labeler NameNorthstar Rx LLC
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength18 mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 16714-124-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-124-01)
Marketing Start Date2019-10-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16714-124-01 [16714012401]

Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA211009
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-10-09

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE18 mg/1

Pharmacological Class

  • Central Nervous System Stimulant [EPC]
  • Central Nervous System Stimulation [PE]
  • Central Nervous System Stimulant [EPC]
  • Central Nervous System Stimulation [PE]

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

NDCBrand NameGeneric Name
68084-805Methylphenidate HydrochlorideMethylphenidate Hydrochloride
68084-816methylphenidate hydrochloridemethylphenidate hydrochloride
68084-823Methylphenidate HydrochlorideMethylphenidate Hydrochloride
68084-829methylphenidate hydrochloridemethylphenidate hydrochloride
68084-833methylphenidate hydrochloridemethylphenidate hydrochloride
0527-2531Methylphenidate HydrochlorideMethylphenidate Hydrochloride
0527-2530Methylphenidate HydrochlorideMethylphenidate Hydrochloride
0527-2532Methylphenidate HydrochlorideMethylphenidate Hydrochloride
69452-167METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE
69452-165METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE
69452-166METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE
70010-042METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE
70010-043METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE
0591-2715methylphenidate hydrochloridemethylphenidate hydrochloride
0591-2716methylphenidate hydrochloridemethylphenidate hydrochloride
0591-2717methylphenidate hydrochloridemethylphenidate hydrochloride
0591-2718methylphenidate hydrochloridemethylphenidate hydrochloride
0591-5882Methylphenidate HydrochlorideMethylphenidate Hydrochloride
0591-5883Methylphenidate HydrochlorideMethylphenidate Hydrochloride
0591-5884Methylphenidate HydrochlorideMethylphenidate Hydrochloride
0603-4577Methylphenidate HydrochlorideMethylphenidate Hydrochloride
0603-4578Methylphenidate HydrochlorideMethylphenidate Hydrochloride
0603-4576Methylphenidate HydrochlorideMethylphenidate Hydrochloride
71335-0838Methylphenidate HydrochlorideMethylphenidate Hydrochloride
71335-0892Methylphenidate HydrochlorideMethylphenidate Hydrochloride
71930-024Methylphenidate HydrochlorideMethylphenidate Hydrochloride
71930-025Methylphenidate HydrochlorideMethylphenidate Hydrochloride
0781-5748Methylphenidate HydrochlorideMethylphenidate Hydrochloride
0781-5749Methylphenidate HydrochlorideMethylphenidate Hydrochloride
0781-5753Methylphenidate HydrochlorideMethylphenidate Hydrochloride
10147-0687methylphenidate Hydrochloridemethylphenidate Hydrochloride
10147-0688methylphenidate Hydrochloridemethylphenidate Hydrochloride
10147-0686methylphenidate Hydrochloridemethylphenidate Hydrochloride
10147-0685methylphenidate Hydrochloridemethylphenidate Hydrochloride
10702-102Methylphenidate HydrochlorideMethylphenidate Hydrochloride
10702-100Methylphenidate HydrochlorideMethylphenidate Hydrochloride
10702-101Methylphenidate HydrochlorideMethylphenidate Hydrochloride
13107-380Methylphenidate HydrochlorideMethylphenidate Hydrochloride
13107-382Methylphenidate HydrochlorideMethylphenidate Hydrochloride
13107-381Methylphenidate HydrochlorideMethylphenidate Hydrochloride
13811-709Methylphenidate HydrochlorideMethylphenidate Hydrochloride
13811-710Methylphenidate HydrochlorideMethylphenidate Hydrochloride
13811-706Methylphenidate HydrochlorideMethylphenidate Hydrochloride
13811-708Methylphenidate HydrochlorideMethylphenidate Hydrochloride
13811-707Methylphenidate HydrochlorideMethylphenidate Hydrochloride
16714-823METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE
16714-821METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE
16714-822METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE
27808-058Methylphenidate HydrochlorideMethylphenidate Hydrochloride
0115-1741Methylphenidate HydrochlorideMethylphenidate Hydrochloride

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.