FDA.reportPublic FDA data

PROVIGIL

Product NDC
21695-234
11-digit product format
216950234
Labeler code
21695
Product ID
21695-234_8b79d52e-e6e5-4aaf-8835-242c72d6ee38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MODAFINIL
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA020717
Marketing category
NDA
Marketing start
2005-06-03
Marketing end
0000-00-00
Substance
MODAFINIL
Active strength
100 mg/1
Pharmacologic classes
Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]
DEA schedule
CIV
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
91b7dea8-da1b-abb1-9750-2e680cd894b6Product name220171005

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-234-152019-09-24C16284748780-1934fe258-4a94-48b1-e053-8cdaa90a720aPROVIGIL ® (modafinil) Tablets [C-IV]
21695-234-302019-09-24C16284748780-1934fe258-4a94-48b1-e053-8cdaa90a720aPROVIGIL ® (modafinil) Tablets [C-IV]

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-234-15PROVIGIL15 in 1 BOTTLETABLET151
21695-234-30PROVIGIL30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-234-15EA - Each21695-234958a7125-41bd-4ea7-96a1-47d4808608ad12012-07-24
21695-234-30EA - Each21695-234d0262f3d-bd16-49ed-874f-98acfcdf7ee812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MODAFINILACTIVE INGREDIENTR3UK8X3U3DPROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]1
MODAFINILACTIVE MOIETYR3UK8X3U3DPROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-234PROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110104_8b79d52e-e6e5-4aaf-8835-242c72d6ee38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260218modafinil 100 MG Oral TabletPSN8b79d52e-e6e5-4aaf-8835-242c72d6ee381
205324modafinil 200 MG Oral TabletPSN8b79d52e-e6e5-4aaf-8835-242c72d6ee381
226426Provigil 100 MG Oral TabletPSN8b79d52e-e6e5-4aaf-8835-242c72d6ee381
213471Provigil 200 MG Oral TabletPSN8b79d52e-e6e5-4aaf-8835-242c72d6ee381
226426modafinil 100 MG Oral Tablet [Provigil]SBD8b79d52e-e6e5-4aaf-8835-242c72d6ee381
213471modafinil 200 MG Oral Tablet [Provigil]SBD8b79d52e-e6e5-4aaf-8835-242c72d6ee381
260218modafinil 100 MG Oral TabletSCD8b79d52e-e6e5-4aaf-8835-242c72d6ee381
205324modafinil 200 MG Oral TabletSCD8b79d52e-e6e5-4aaf-8835-242c72d6ee381
226426Provigil 100 MG Oral TabletSY8b79d52e-e6e5-4aaf-8835-242c72d6ee381
213471Provigil 200 MG Oral TabletSY8b79d52e-e6e5-4aaf-8835-242c72d6ee381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-234-152169502341515 in 1 BOTTLEHistorical
21695-234-302169502343030 in 1 BOTTLEHistorical