FDA.reportPublic FDA data

NDC 63629-7315-00 - Modafinil

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63629-7315
Requested NDC
63629-7315-00
Package NDCs from labels
63629-7315-1, 63629-7315-2, 63629-7315-3, 63629-7315-4, 63629-7315-5, 63629-7315-6, 63629-7315-7, 63629-7315-8, 63629-7315-9, 63629-7315-0, 63629-7315-00
Manufacturer
Bryant Ranch Prepack
Effective date
2024-07-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Modafinil - Bryant Ranch PrepackBryant Ranch Prepack2024-07-08HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-7315-12024-07-22These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-22024-07-22These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-32024-07-22These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-42024-07-22These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-52024-07-22These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-62024-07-22These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-72024-07-22These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-82024-07-22These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-92024-07-22These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-12024-01-30These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-22024-01-30These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-32024-01-30These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-42024-01-30These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-52024-01-30These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-62024-01-30These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-72024-01-30These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-82024-01-30These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-92024-01-30These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7315-0Modafinil100 in 1 BOTTLETABLET10010
63629-7315-1Modafinil30 in 1 BOTTLETABLET3010
63629-7315-2Modafinil18 in 1 BOTTLETABLET1810
63629-7315-3Modafinil16 in 1 BOTTLETABLET1610
63629-7315-4Modafinil8 in 1 BOTTLETABLET810
63629-7315-5Modafinil10 in 1 BOTTLETABLET1010
63629-7315-6Modafinil60 in 1 BOTTLETABLET6010
63629-7315-7Modafinil90 in 1 BOTTLETABLET9010
63629-7315-8Modafinil45 in 1 BOTTLETABLET4510
63629-7315-9Modafinil180 in 1 BOTTLETABLET18010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7315MODAFINIL TABLET [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 10 package rows20240724_f0c43046-fc86-4b62-bd0f-704a6894625d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ModafinilMODAFINILProficient Rx LPc332ea93-48d9-4c8a-a1ef-01c27a61350b2024-07-01Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D
ModafinilMODAFINILNuCare Pharmaceuticals,Inc.98e54b10-8ae0-7c43-e053-2a95a90ae8bb2024-06-20Warnings, Adverse reactionsExact identifier
application number: ANDA202566
rxcui: 260218
unii: R3UK8X3U3D
ModafinilMODAFINILRising Pharma Holdings, Inc.4b63aac6-4385-44a3-8390-cdbb0b4b5fe02024-05-27Warnings, Adverse reactionsExact identifier
application number: ANDA202566
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D
ModafinilMODAFINILAurobindo Pharma Limitedf51ca007-3955-4540-a88a-0ddae8d8e8ab2024-05-27Warnings, Adverse reactionsExact identifier
application number: ANDA202566
ndc (product): 65862-602
rxcui: 205324
rxcui: 260218
spl id: f2c9beee-f9fc-44c5-bbbd-0d617c04ab0d
spl set id: f51ca007-3955-4540-a88a-0ddae8d8e8ab
unii: R3UK8X3U3D
ModafinilMODAFINILBryant Ranch Prepackdd1454b3-8599-4dfa-aaf7-b8a3ebe85acd2024-04-03Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D
ModafinilMODAFINILViona Pharmaceuticals Inc15739a31-2433-49b5-90ea-b974214f73be2023-11-10Warnings, Adverse reactionsExact identifier
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D
ModafinilMODAFINILBionpharma Inc.63604fef-0b80-40ce-8dbf-3384f1aee3952023-07-21Warnings, Adverse reactionsExact identifier
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D
ModafinilMODAFINILProficient Rx LPd97684d7-c236-451e-99bd-b8df4bf366432023-06-01Warnings, Adverse reactionsExact identifier
application number: ANDA202566
rxcui: 205324
unii: R3UK8X3U3D
ModafinilMODAFINILCIMA LABS INC.9f3b0bd2-72a3-411f-aeec-b533373f1a972023-01-31Warnings, Adverse reactionsExact identifier
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D
ModafinilMODAFINILAphena Pharma Solutions - Tennessee, LLCa4a27496-0f5a-4ea8-b48c-72fcb323dc8f2023-01-16Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D
ModafinilMODAFINILProficient Rx LPccf7836d-c131-4e7d-a339-fbf99fe7f4492023-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA202566
rxcui: 260218
unii: R3UK8X3U3D
ProvigilMODAFINILCephalon, LLCe16c26ad-7bc2-d155-3a5d-da83ad6492c82022-12-31Warnings, Adverse reactionsExact identifier
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D
ModafinilMODAFINILAlembic Pharmaceuticals Limited5b8496fe-b647-4ce6-aeef-71245712e46f2022-06-03Warnings, Adverse reactionsExact identifier
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D
ModafinilMODAFINILAlembic Pharmaceuticals Inc.41f9ddbd-5228-4f0c-b0aa-2056af79a21e2021-10-01Warnings, Adverse reactionsExact identifier
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D
modafinilMODAFINILAphena Pharma Solutions - Tennessee, LLCcad4201c-133c-4a61-9d93-3c5e516954302017-12-19Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.