NDC 35356-372

PROVIGIL

Modafinil

PROVIGIL is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Surgical & Supply Dba Quality Care Products Llc. The primary component is Modafinil.

Product ID35356-372_f230bd1c-4c8f-496c-bcf5-e727d7fa94c0
NDC35356-372
Product TypeHuman Prescription Drug
Proprietary NamePROVIGIL
Generic NameModafinil
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-07-20
Marketing CategoryNDA / NDA
Application NumberNDA020717
Labeler NameLake Erie Medical Surgical & Supply DBA Quality Care Products LLC
Substance NameMODAFINIL
Active Ingredient Strength200 mg/1
Pharm ClassesCentral Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 35356-372-30

30 TABLET in 1 BOTTLE (35356-372-30)
Marketing Start Date2011-07-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-372-30 [35356037230]

PROVIGIL TABLET
Marketing CategoryNDA
Application NumberNDA020717
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-07-20
Marketing End Date2019-10-11

Drug Details

Active Ingredients

IngredientStrength
MODAFINIL200 mg/1

OpenFDA Data

SPL SET ID:a85d5629-748d-4920-b0d6-3012a0ace1a3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 213471
  • 205324

    • Pharmacological Class

    • Central Nervous System Stimulation [PE]
    • Increased Sympathetic Activity [PE]
    • Sympathomimetic-like Agent [EPC]

    NDC Crossover Matching brand name "PROVIGIL" or generic name "Modafinil"

    NDCBrand NameGeneric Name
    21695-234PROVIGILMODAFINIL
    21695-235PROVIGILMODAFINIL
    35356-372PROVIGILmodafinil
    50436-0201ProvigilProvigil
    63459-101ProvigilProvigil
    63459-201ProvigilProvigil
    0143-9968Modafinilmodafinil
    0143-9969Modafinilmodafinil
    0378-5573Modafinilmodafinil
    0378-5575Modafinilmodafinil
    0591-3499ModafinilModafinil
    0591-3500ModafinilModafinil
    0904-6423ModafinilModafinil
    0904-6424ModafinilModafinil
    0904-6791Modafinilmodafinil
    0904-6792Modafinilmodafinil
    23155-604ModafinilModafinil
    23155-605ModafinilModafinil
    42043-160ModafinilModafinil
    42043-161ModafinilModafinil
    42291-599ModafinilModafinil
    42291-600ModafinilModafinil
    43353-831Modafinilmodafinil
    43353-925modafinilmodafinil
    43353-956ModafinilModafinil
    46708-385ModafinilModafinil
    46708-386ModafinilModafinil
    49884-534ModafinilModafinil

    Trademark Results [PROVIGIL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PROVIGIL
    PROVIGIL
    76033426 2499937 Live/Registered
    CEPHALON, INC.
    2000-04-21
    PROVIGIL
    PROVIGIL
    74507491 2000231 Live/Registered
    CEPHALON, INC.
    1994-03-31
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