FDA.reportPublic FDA data

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 4 of 6 · 101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ModafinilMODAFINILAphena Pharma Solutions - Tennessee, LLC2bc3cd03-2726-f693-e063-6294a90a7a032025-02-21Warnings, Adverse reactionsExact identifier
application number: ANDA209966
rxcui: 205324
unii: R3UK8X3U3D
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E
ModafinilMODAFINILAmerican Health Packaging928a3ab6-b53c-4924-882c-9f2f49aba0f12024-10-31Warnings, Adverse reactionsExact identifier
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
unii: FZ989GH94E
ModafinilMODAFINILBryant Ranch Prepack3f733d7f-1213-4534-9433-0eb99a5abc2c2024-09-23Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D
ModafinilMODAFINILBryant Ranch Prepack963aa6be-5aed-4865-b375-8c2c3102e7bc2024-08-27Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D
ModafinilMODAFINILZydus Lifesciences Limitedf39820fb-8248-4d42-854c-6fe2d9b92d362024-08-16Exact identifier
application number: ANDA209966
ndc (package): 70771-1052-1
ndc (package): 70771-1052-9
ndc (package): 70771-1051-1
ndc (package): 70771-1051-9
ndc (package): 70771-1052-3
ndc (package): 70771-1051-3
ndc (product): 70771-1051
ndc (product): 70771-1052
ndc11 (package): 70771105201
rxcui: 205324
rxcui: 260218
spl id: e22df34a-3c16-4062-9882-be9840afb8cf
spl set id: f39820fb-8248-4d42-854c-6fe2d9b92d36
unii: R3UK8X3U3D
ModafinilMODAFINILBryant Ranch Prepackf1ff7c6d-df04-48dd-a971-454d38e7d9972024-07-09Warnings, Adverse reactionsExact identifier
rxcui: 260218
unii: R3UK8X3U3D
ModafinilMODAFINILBryant Ranch Prepackf0c43046-fc86-4b62-bd0f-704a6894625d2024-07-08Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D
ModafinilMODAFINILProficient Rx LPc332ea93-48d9-4c8a-a1ef-01c27a61350b2024-07-01Warnings, Adverse reactionsExact identifier
application number: ANDA209966
rxcui: 205324
unii: R3UK8X3U3D
ModafinilMODAFINILNuCare Pharmaceuticals,Inc.98e54b10-8ae0-7c43-e053-2a95a90ae8bb2024-06-20Warnings, Adverse reactionsExact identifier
rxcui: 260218
unii: R3UK8X3U3D
Artificial TearsPOLYVINYL ALCOHOL, POVIDONENuCare Pharmaceuticals,Inc.9c1c4911-908e-3c3c-e053-2995a90abcfc2024-06-14WarningsExact identifier
unii: FZ989GH94E
ModafinilMODAFINILRising Pharma Holdings, Inc.4b63aac6-4385-44a3-8390-cdbb0b4b5fe02024-05-27Warnings, Adverse reactionsExact identifier
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D
ModafinilMODAFINILAurobindo Pharma Limitedf51ca007-3955-4540-a88a-0ddae8d8e8ab2024-05-27Warnings, Adverse reactionsExact identifier
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D
ModafinilMODAFINILBryant Ranch Prepackdd1454b3-8599-4dfa-aaf7-b8a3ebe85acd2024-04-03Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D
Clear Eyes Natural TearsPOLYVINYL ALCOHOL AND POVIDONEPrestige Brands Holdings, Inc.efba3eb0-798d-4635-b19b-4970e45b3cc92024-04-01WarningsExact identifier
unii: FZ989GH94E
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
REFRESH CLASSICPOLYVINYL ALCOHOL, POVIDONEA-S Medication Solutions3bf6193c-56db-45ad-844c-58eb8c33cba92024-03-14WarningsExact identifier
unii: FZ989GH94E
GOODSENSE ARTIFICIAL TEARSPOLYVINYL ALCOHOLProficient Rx LPf29c792c-6cb2-449f-b97d-6304a58dec2a2024-02-01WarningsExact identifier
unii: FZ989GH94E
GoodSense Artifical TearsPOLYVINYL ALCOHOL, AND POVIDONEProficient Rx LPcd24da78-fd90-4a9c-8e5f-f7fc56ec0fc92024-02-01WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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