NDC 0378-3431

Armodafinil

Armodafinil

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

Product ID0378-3431_2c12075d-4a65-47d0-931a-644bb189ae04
NDC0378-3431
Product TypeHuman Prescription Drug
Proprietary NameArmodafinil
Generic NameArmodafinil
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-06-01
Marketing CategoryANDA / ANDA
Application NumberANDA200043
Labeler NameMylan Pharmaceuticals Inc.
Substance NameARMODAFINIL
Active Ingredient Strength50 mg/1
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-3431-93

30 TABLET in 1 BOTTLE, PLASTIC (0378-3431-93)
Marketing Start Date2016-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-3431-93 [00378343193]

Armodafinil TABLET
Marketing CategoryANDA
Application NumberANDA200043
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-06-01

Drug Details

Active Ingredients

IngredientStrength
ARMODAFINIL50 mg/1

OpenFDA Data

SPL SET ID:de0799f7-7644-4057-a7da-75436f978c61
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 724863
  • 724861
  • 724859
  • UPC Code
  • 0303783433936
  • 0303783432939
  • 0303783431932
  • NDC Crossover Matching brand name "Armodafinil" or generic name "Armodafinil"

    NDCBrand NameGeneric Name
    0093-3090ArmodafinilArmodafinil
    0093-3092ArmodafinilArmodafinil
    0093-3093ArmodafinilArmodafinil
    0093-3094ArmodafinilArmodafinil
    0378-3431Armodafinilarmodafinil
    0378-3432Armodafinilarmodafinil
    0378-3433Armodafinilarmodafinil
    0591-3856ArmodafinilArmodafinil
    0781-8029ArmodafinilArmodafinil
    0781-8037ArmodafinilArmodafinil
    0781-8045ArmodafinilArmodafinil
    68180-571ArmodafinilArmodafinil
    68180-572ArmodafinilArmodafinil
    68180-573ArmodafinilArmodafinil
    68180-569ArmodafinilArmodafinil
    68788-7176ArmodafinilArmodafinil
    71335-0710ArmodafinilArmodafinil
    71335-0681ArmodafinilArmodafinil
    0781-8053ArmodafinilArmodafinil
    51991-322ArmodafinilArmodafinil
    51991-323ArmodafinilArmodafinil
    51991-324ArmodafinilArmodafinil
    55700-510ArmodafinilArmodafinil
    59651-047ARMODAFINILARMODAFINIL
    61919-770ArmodafinilArmodafinil
    61919-562ARMODAFINILARMODAFINIL
    63629-7403ArmodafinilArmodafinil
    63629-7390ArmodafinilArmodafinil
    65862-806ArmodafinilArmodafinil
    65862-805ArmodafinilArmodafinil
    65862-998ArmodafinilArmodafinil
    65862-807ArmodafinilArmodafinil
    71335-1193ArmodafinilArmodafinil
    68788-7426ArmodafinilArmodafinil
    71335-1308ArmodafinilArmodafinil
    72189-041ARMODAFINILARMODAFINIL

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