NDC 62332-385

Modafinil

Modafinil

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

Product ID62332-385_1ab6cc65-5137-4224-9965-7c53a8aac14b
NDC62332-385
Product TypeHuman Prescription Drug
Proprietary NameModafinil
Generic NameModafinil
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-06-30
Marketing CategoryANDA / ANDA
Application NumberANDA202700
Labeler NameAlembic Pharmaceuticals Inc.
Substance NameMODAFINIL
Active Ingredient Strength100 mg/1
Pharm ClassesCentral Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 62332-385-10

100 TABLET in 1 CARTON (62332-385-10)
Marketing Start Date2017-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62332-385-60 [62332038560]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA202700
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-30

NDC 62332-385-90 [62332038590]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA202700
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-30

NDC 62332-385-30 [62332038530]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA202700
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-30

NDC 62332-385-10 [62332038510]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA202700
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-30

NDC 62332-385-91 [62332038591]

Modafinil TABLET
Marketing CategoryANDA
Application NumberANDA202700
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-30

Drug Details

Active Ingredients

IngredientStrength
MODAFINIL100 mg/1

OpenFDA Data

SPL SET ID:41f9ddbd-5228-4f0c-b0aa-2056af79a21e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205324
  • 260218
    • UPC Code
  • 0362332385300
  • 0362332386307

    • Pharmacological Class

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

    Medicade Reported Pricing

    62332038590 MODAFINIL 100 MG TABLET

    Pricing Unit: EA | Drug Type:

    62332038530 MODAFINIL 100 MG TABLET

    Pricing Unit: EA | Drug Type:

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