FDA.reportPublic FDA data

Provigil

Product NDC
63459-201
11-digit product format
634590201
Labeler code
63459
Product ID
63459-201_a505a386-c2a1-4a32-9523-b33b1528fb48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Modafinil
Dosage form
TABLET
Route
ORAL
Labeler
Cephalon, LLC
Application
NDA020717
Marketing category
NDA
Marketing start
1999-02-15
Marketing end
2027-08-31
Substance
MODAFINIL
Active strength
200 mg/1
Pharmacologic classes
Central Nervous System Stimulation [PE], Increased Sympathetic Activity [PE], Sympathomimetic-like Agent [EPC]
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Provigil

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MODAFINIL200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR3UK8X3U3D
Rxcui205324, 213471, 226426, 260218

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63459-201-01Provigil100 in 1 BOTTLETABLET10023
63459-201-30Provigil30 in 1 BOTTLETABLET3023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63459-201-01EA - Each63459-20163599ee2-5ec1-4665-a5f2-b461284395bc12012-07-24
63459-201-30EA - Each63459-201bc73e54d-2486-4261-9f76-47da1a62effa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MODAFINILACTIVE INGREDIENTR3UK8X3U3DPROVIGIL (MODAFINIL) TABLET [CEPHALON, INCORPORATED]7
MODAFINILACTIVE MOIETYR3UK8X3U3DPROVIGIL (MODAFINIL) TABLET [CEPHALON, INCORPORATED]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROVIGIL (MODAFINIL) TABLET [CEPHALON, INCORPORATED]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PROVIGIL (MODAFINIL) TABLET [CEPHALON, INCORPORATED]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROVIGIL (MODAFINIL) TABLET [CEPHALON, INCORPORATED]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROVIGIL (MODAFINIL) TABLET [CEPHALON, INCORPORATED]7
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQPROVIGIL (MODAFINIL) TABLET [CEPHALON, INCORPORATED]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROVIGIL (MODAFINIL) TABLET [CEPHALON, INCORPORATED]7
MODAFINILACTIVE INGREDIENTR3UK8X3U3DPROVIGIL (MODAFINIL) TABLET [PHYSICIANS TOTAL CARE, INC.]2
MODAFINILACTIVE MOIETYR3UK8X3U3DPROVIGIL (MODAFINIL) TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROVIGIL (MODAFINIL) TABLET [PHYSICIANS TOTAL CARE, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PROVIGIL (MODAFINIL) TABLET [PHYSICIANS TOTAL CARE, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPROVIGIL (MODAFINIL) TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROVIGIL (MODAFINIL) TABLET [PHYSICIANS TOTAL CARE, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EPROVIGIL (MODAFINIL) TABLET [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROVIGIL (MODAFINIL) TABLET [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63459-201PROVIGIL (MODAFINIL) TABLET [CEPHALON, LLC]23Current NDC, Legacy NDC, 2 package rows20250321_e16c26ad-7bc2-d155-3a5d-da83ad6492c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260218modafinil 100 MG Oral TabletPSNe16c26ad-7bc2-d155-3a5d-da83ad6492c823
205324modafinil 200 MG Oral TabletPSNe16c26ad-7bc2-d155-3a5d-da83ad6492c823
226426Provigil 100 MG Oral TabletPSNe16c26ad-7bc2-d155-3a5d-da83ad6492c823
213471Provigil 200 MG Oral TabletPSNe16c26ad-7bc2-d155-3a5d-da83ad6492c823
226426modafinil 100 MG Oral Tablet [Provigil]SBDe16c26ad-7bc2-d155-3a5d-da83ad6492c823
213471modafinil 200 MG Oral Tablet [Provigil]SBDe16c26ad-7bc2-d155-3a5d-da83ad6492c823
260218modafinil 100 MG Oral TabletSCDe16c26ad-7bc2-d155-3a5d-da83ad6492c823
205324modafinil 200 MG Oral TabletSCDe16c26ad-7bc2-d155-3a5d-da83ad6492c823
226426Provigil 100 MG Oral TabletSYe16c26ad-7bc2-d155-3a5d-da83ad6492c823
213471Provigil 200 MG Oral TabletSYe16c26ad-7bc2-d155-3a5d-da83ad6492c823
260218modafinil 100 MG Oral TabletPSN5053c113-69df-4ade-a186-02bc054c23d12
205324modafinil 200 MG Oral TabletPSN5053c113-69df-4ade-a186-02bc054c23d12
226426Provigil 100 MG Oral TabletPSN5053c113-69df-4ade-a186-02bc054c23d12
213471Provigil 200 MG Oral TabletPSN5053c113-69df-4ade-a186-02bc054c23d12
226426modafinil 100 MG Oral Tablet [Provigil]SBD5053c113-69df-4ade-a186-02bc054c23d12
213471modafinil 200 MG Oral Tablet [Provigil]SBD5053c113-69df-4ade-a186-02bc054c23d12
260218modafinil 100 MG Oral TabletSCD5053c113-69df-4ade-a186-02bc054c23d12
205324modafinil 200 MG Oral TabletSCD5053c113-69df-4ade-a186-02bc054c23d12
226426Provigil 100 MG Oral TabletSY5053c113-69df-4ade-a186-02bc054c23d12
213471Provigil 200 MG Oral TabletSY5053c113-69df-4ade-a186-02bc054c23d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63459-201-0163459020101100 in 1 BOTTLEHistorical
63459-201-306345902013030 TABLET in 1 BOTTLE (63459-201-30) 30 tablet2011-01-032027-08-31NoNoCurrent