NDC 0378-5575

Modafinil

Modafinil

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

Product ID0378-5575_f6947bbc-082d-48f6-ab5e-06610359865d
NDC0378-5575
Product TypeHuman Prescription Drug
Proprietary NameModafinil
Generic NameModafinil
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-08-10
Marketing CategoryANDA / ANDA
Application NumberANDA076594
Labeler NameMylan Pharmaceuticals Inc.
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 Through2020-12-31

Packaging

NDC 0378-5575-05

500 TABLET in 1 BOTTLE, PLASTIC (0378-5575-05)
Marketing Start Date2012-08-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-5575-01 [00378557501]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA076594
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-10
Marketing End Date2014-03-31

NDC 0378-5575-05 [00378557505]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA076594
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-10

NDC 0378-5575-93 [00378557593]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA076594
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-10

NDC 0378-5575-77 [00378557577]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA076594
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-29
Marketing End Date2014-03-31

Drug Details

Active Ingredients

IngredientStrength
MODAFINIL200 mg/1

OpenFDA Data

SPL SET ID:f3b3097f-80b8-4410-af21-dcdea144e3c3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205324
  • 260218

    • Pharmacological Class

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