NDC 0781-8045

Armodafinil

Armodafinil

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

Product ID0781-8045_568f4aa8-ee76-45b0-844a-c9005bc65d56
NDC0781-8045
Product TypeHuman Prescription Drug
Proprietary NameArmodafinil
Generic NameArmodafinil
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-12-01
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021875
Labeler NameSandoz Inc
Substance NameARMODAFINIL
Active Ingredient Strength200 mg/1
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0781-8045-31

30 TABLET in 1 BOTTLE (0781-8045-31)
Marketing Start Date2016-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-8045-31 [00781804531]

Armodafinil TABLET
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA021875
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-12-01

Drug Details

Active Ingredients

IngredientStrength
ARMODAFINIL200 mg/1

OpenFDA Data

SPL SET ID:a3341ec8-1ad4-49e2-922b-13d1b30c8c1d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 724863
  • 724861
  • 724859
  • 861960
  • UPC Code
  • 0307818037311
  • 0307818045316
  • 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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