NDC 40032-575

Methylphenidate Hydrochloride

Methylphenidate Hydrochloride

Methylphenidate Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Novel Laboratories, Inc.. The primary component is Methylphenidate Hydrochloride.

Product ID40032-575_07e58ef7-4278-4994-a6f3-ac37d27c3655
NDC40032-575
Product TypeHuman Prescription Drug
Proprietary NameMethylphenidate Hydrochloride
Generic NameMethylphenidate Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-11-13
Marketing CategoryANDA / ANDA
Application NumberANDA207884
Labeler NameNovel Laboratories, Inc.
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength20 mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 40032-575-05

500 TABLET in 1 BOTTLE (40032-575-05)
Marketing Start Date2015-11-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 40032-575-05 [40032057505]

Methylphenidate Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA207884
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-11-13
Inactivation Date2020-01-31

NDC 40032-575-03 [40032057503]

Methylphenidate Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA207884
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-11-13
Inactivation Date2020-01-31

NDC 40032-575-01 [40032057501]

Methylphenidate Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA207884
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-11-13
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:e5e705f5-e4f2-46c0-a157-1b4f7413807e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1091497
  • 1091392
  • 1091150

    • Pharmacological Class

    • 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
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