NDC 71335-1122-01 - 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
71335-1122
Requested NDC
71335-1122-01
Package NDCs from labels
71335-1122-1, 71335-1122-2, 71335-1122-3, 71335-1122-4, 71335-1122-5, 71335-1122-6, 71335-1122-7, 71335-1122-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-07-09
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 Prepack2024-07-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1122-1Modafinil30 in 1 BOTTLETABLET308
71335-1122-2Modafinil60 in 1 BOTTLETABLET608
71335-1122-3Modafinil28 in 1 BOTTLETABLET288
71335-1122-4Modafinil90 in 1 BOTTLETABLET908
71335-1122-5Modafinil45 in 1 BOTTLETABLET458
71335-1122-6Modafinil180 in 1 BOTTLETABLET1808
71335-1122-7Modafinil100 in 1 BOTTLETABLET1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1122MODAFINIL TABLET [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 7 package rows20240724_f1ff7c6d-df04-48dd-a971-454d38e7d997.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1122-1EA - Each71335-1122f866b1b5-5197-4416-bb81-4a0b02d003a212022-07-06

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
ndc (product): 57237-154
rxcui: 205324
rxcui: 260218
spl id: 2f270ddd-1b6f-40bf-bfdc-c3f47f716dd1
spl set id: 4b63aac6-4385-44a3-8390-cdbb0b4b5fe0
unii: R3UK8X3U3D
ModafinilMODAFINILAurobindo Pharma Limitedf51ca007-3955-4540-a88a-0ddae8d8e8ab2024-05-27Warnings, Adverse reactionsExact identifier
application number: ANDA202566
rxcui: 205324
rxcui: 260218
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.