NDC 72578-005

Modafinil

Modafinil

Modafinil is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Viona Pharmaceuticals Inc. The primary component is Modafinil.

Product ID72578-005_16e4e243-a7de-40c0-8991-2244d78f9361
NDC72578-005
Product TypeHuman Prescription Drug
Proprietary NameModafinil
Generic NameModafinil
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-02-15
Marketing CategoryANDA / ANDA
Application NumberANDA209966
Labeler NameViona Pharmaceuticals Inc
Substance NameMODAFINIL
Active Ingredient Strength100 mg/1
Pharm ClassesCentral Nervous System Stimulation [PE], Increased Sympathetic Activity [PE], Sympathomimetic-like Agent [EPC]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 72578-005-01

100 TABLET in 1 BOTTLE (72578-005-01)
Marketing Start Date2019-02-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72578-005-01 [72578000501]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA209966
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-15

NDC 72578-005-16 [72578000516]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA209966
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-15

NDC 72578-005-06 [72578000506]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA209966
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-15

Drug Details

Active Ingredients

IngredientStrength
MODAFINIL100 mg/1

OpenFDA Data

SPL SET ID:15739a31-2433-49b5-90ea-b974214f73be
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205324
  • 260218
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    68084-721ModafinilModafinil
    68084-621ModafinilModafinil
    68258-7981modafinilmodafinil
    68788-7408ModafinilModafinil
    70710-1073ModafinilModafinil
    70710-1072ModafinilModafinil
    70771-1051ModafinilModafinil
    70771-1052ModafinilModafinil
    71335-0259ModafinilModafinil
    71335-0811ModafinilModafinil
    71335-0997ModafinilModafinil
    72578-005ModafinilModafinil
    72578-006ModafinilModafinil
    49884-535ModafinilModafinil
    50090-2472ModafinilModafinil
    50090-2473ModafinilModafinil
    50090-3865ModafinilModafinil
    50268-570ModafinilModafinil
    50090-4144ModafinilModafinil
    50268-571ModafinilModafinil
    50742-153ModafinilModafinil
    50742-152ModafinilModafinil
    51079-561ModafinilModafinil
    51079-562ModafinilModafinil
    55253-801ModafinilModafinil
    55253-802ModafinilModafinil
    55700-695ModafinilModafinil
    55700-688ModafinilModafinil

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