FDA.reportPublic FDA data

NDC 50268-570-11 - 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
50268-570
Requested NDC
50268-570-11
Package NDCs from labels
50268-570-11, 50268-570-12
Manufacturer
AvPAK
Effective date
2026-01-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Modafinil - AvPAKAvPAK2026-01-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-570-11Modafinil1 in 1 BLISTER PACKTABLET16
50268-570-12Modafinil20 in 1 BOXTABLET206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-570MODAFINIL TABLET [AVPAK]5Current NDC, Legacy NDC, 2 package rows20220603_4790bbe9-d753-1067-02ee-9536011650d9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-570-11EA - Each50268-570cddf7fa0-3cf7-45c8-bdc5-cdbaf2b6a1f312016-09-02
50268-570-12EA - Each50268-57018315cb4-7a72-4214-bfe4-fbc361e2191212016-09-02

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 1 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ModafinilMODAFINILHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1a309416-bd6a-45b1-982f-b689b097453d2026-09-03Warnings, Adverse reactionsExact identifier
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D
ModafinilMODAFINILApotex Corp.944daf47-49a6-93ca-e348-4a0f1b6d937e2026-07-21Warnings, Adverse reactionsExact identifier
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D
ModafinilMODAFINILPreferred Pharmaceuticals Inc.60ec6e2a-2576-498f-9a8c-fddc53d4a44c2026-07-17Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D
ModafinilMODAFINILPreferred Pharmaceuticals Inc.013450dd-cd42-46c7-98d6-9a29257619782026-07-14Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D
ModafinilMODAFINILGolden State Medical Supply, Inc.1d4c6858-5b2f-f216-e063-6394a90aad5d2026-03-16Warnings, Adverse reactionsExact identifier
rxcui: 260218
unii: R3UK8X3U3D
ModafinilMODAFINILAphena Pharma Solutions - Tennessee, LLC4c9c4e61-517c-a9d2-e063-6394a90a58c72026-03-09Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D
ModafinilMODAFINILAphena Pharma Solutions - Tennessee, LLC4aa3bdad-163f-fda1-e063-6394a90ae1d82026-02-12Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D
ModafinilMODAFINILAvPAK4790bbe9-d753-1067-02ee-9536011650d92026-01-08Warnings, Adverse reactionsExact identifier
application number: ANDA202566
ndc (package): 50268-570-12
ndc (package): 50268-570-11
ndc (package): 50268-571-12
ndc (package): 50268-571-11
ndc (product): 50268-570
ndc (product): 50268-571
ndc11 (package): 50268057011
rxcui: 205324
rxcui: 260218
spl id: 47e7afcc-7429-1e31-e063-6394a90ab335
spl set id: 4790bbe9-d753-1067-02ee-9536011650d9
unii: R3UK8X3U3D
ModafinilMODAFINILAphena Pharma Solutions - Tennessee, LLC463bb960-a0b5-4ca4-e063-6294a90a683b2025-12-18Warnings, Adverse reactionsExact identifier
rxcui: 260218
unii: R3UK8X3U3D
ModafinilMODAFINILGolden State Medical Supply, Inc.457662d8-b95c-d3af-e063-6294a90a883e2025-12-08Warnings, Adverse reactionsExact identifier
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D
ProvigilMODAFINILGolden State Medical Supply, Inc.3b8d1c32-dac9-50e6-e063-6394a90aa5a52025-10-16Warnings, Adverse reactionsExact identifier
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D
ProvigilMODAFINILApotex Corp0391f182-1958-9fef-a944-53b229ce99e72025-08-27Warnings, Adverse reactionsExact identifier
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D
ModafinilMODAFINILMajor Pharmaceuticals4a7ab52b-db31-4774-a06a-b11f2bb606622025-03-11Warnings, Adverse reactionsExact identifier
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D
ModafinilMODAFINILAphena Pharma Solutions - Tennessee, LLC2bc3cd03-2726-f693-e063-6294a90a7a032025-02-21Warnings, Adverse reactionsExact identifier
rxcui: 205324
unii: R3UK8X3U3D
ModafinilMODAFINILAmerican Health Packaging928a3ab6-b53c-4924-882c-9f2f49aba0f12024-10-31Warnings, Adverse reactionsExact identifier
application number: ANDA202566
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D
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
application number: ANDA202566
rxcui: 205324
unii: R3UK8X3U3D
ModafinilMODAFINILZydus Lifesciences Limitedf39820fb-8248-4d42-854c-6fe2d9b92d362024-08-16Exact identifier
rxcui: 205324
rxcui: 260218
unii: R3UK8X3U3D
ModafinilMODAFINILBryant Ranch Prepackf1ff7c6d-df04-48dd-a971-454d38e7d9972024-07-09Warnings, Adverse reactionsExact identifier
application number: ANDA202566
rxcui: 260218
unii: R3UK8X3U3D
ModafinilMODAFINILBryant Ranch Prepackf0c43046-fc86-4b62-bd0f-704a6894625d2024-07-08Warnings, Adverse reactionsExact identifier
application number: ANDA202566
rxcui: 205324
unii: R3UK8X3U3D

Reported adverse events (FAERS/openFDA)#

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