NDC 70771-1052-01 - 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
70771-1052
Requested NDC
70771-1052-01
Package NDCs from labels
70771-1052-3, 70771-1052-9, 70771-1052-1, 70771-1052-01
Manufacturer
Zydus Lifesciences Limited
Effective date
2024-08-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Modafinil - Zydus Lifesciences LimitedZydus Lifesciences Limited2024-08-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1052-1Modafinil100 in 1 BOTTLETABLET1006
70771-1052-3Modafinil30 in 1 BOTTLETABLET306
70771-1052-9Modafinil90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1052MODAFINIL TABLET [ZYDUS LIFESCIENCES LIMITED]6Current NDC, Legacy NDC, 3 package rows20240821_f39820fb-8248-4d42-854c-6fe2d9b92d36.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 6 of 6 · 101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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.