72578-006 NDC - MODAFINIL

Drug Information

  • Product NDC: 72578-006
  • Proprietary Name: Modafinil
  • Non Proprietary Name: Modafinil
  • Active Ingredient(s): 200 mg/1 MODAFINIL
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET
  • Pharmacy Class(es): Central Nervous System Stimulation [PE]; Increased Sympathetic Activity [PE]; Sympathomimetic-like Agent [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Viona Pharmaceuticals Inc
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA209966
Marketing Category: ANDA
Start Marketing Date:2/15/2019
DEA Schedule:CIV

Package Information

No. Package Code Package Description Billing Unit
172578-006-01100 TABLET in 1 BOTTLE (72578-006-01)EA
272578-006-0630 TABLET in 1 BOTTLE (72578-006-06)EA
372578-006-1690 TABLET in 1 BOTTLE (72578-006-16)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC72578-006The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
PROPRIETARY NAMEModafinilThis is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
NON PROPRIETARY NAMEModafinilName of Company corresponding to the labeler code segment of the Product NDC.
DOSAGE FORM NAMETABLETThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE2/15/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA209966This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEViona Pharmaceuticals IncName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEMODAFINILAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH200 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESCentral Nervous System Stimulation [PE], Increased Sympathetic Activity [PE], Sympathomimetic-like Agent [EPC] 
DEA SCHEDULECIVThis is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

Download Record

Download this NDC record record in Text format: Export

Download this NDC record record in Excel (CSV) format: Export

Download this NDC record record in XML format: Export

This page was last updated on: 12/6/2025

Previous Code
Next Code