FDA.reportPublic FDA data

NDC 68084-621-11 - 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
68084-621
Requested NDC
68084-621-11
Package NDCs from labels
68084-621-11, 68084-621-21
Manufacturer
American Health Packaging
Effective date
2024-10-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Modafinil - American Health PackagingAmerican Health Packaging2024-10-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-621-11Modafinil1 in 1 BLISTER PACKTABLET111
68084-621-21Modafinil30 in 1 BOX, UNIT-DOSETABLET3011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-621MODAFINIL TABLET [AMERICAN HEALTH PACKAGING]11Current NDC, Legacy NDC, 2 package rows20241102_928a3ab6-b53c-4924-882c-9f2f49aba0f1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-621-11EA - Each68084-6213826800f-6b7f-48df-9d77-ea6a10d90a9312013-07-02
68084-621-21EA - Each68084-62101e54d53-1838-479d-a0c5-6d104d3e311912013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MODAFINILACTIVE INGREDIENTR3UK8X3U3DMODAFINIL TABLET [AMERICAN HEALTH PACKAGING]3
MODAFINILACTIVE MOIETYR3UK8X3U3DMODAFINIL TABLET [AMERICAN HEALTH PACKAGING]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MODAFINIL TABLET [AMERICAN HEALTH PACKAGING]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMODAFINIL TABLET [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MODAFINIL TABLET [AMERICAN HEALTH PACKAGING]3
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMODAFINIL TABLET [AMERICAN HEALTH PACKAGING]3

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
rxcui: 205324
rxcui: 260218
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
ndc (package): 68084-621-11
ndc (package): 68084-721-11
ndc (package): 68084-721-21
ndc (package): 68084-621-21
ndc (product): 68084-721
ndc (product): 68084-621
ndc11 (package): 68084062111
rxcui: 205324
rxcui: 260218
spl id: 25c5e078-ef5a-651d-e063-6394a90a2845
spl set id: 928a3ab6-b53c-4924-882c-9f2f49aba0f1
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.