FDA.reportPublic FDA data

NDC 60505-4849-03 - Nuvigil

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
60505-4849
Requested NDC
60505-4849-03
Package NDCs from labels
60505-4849-3, 60505-4849-03
Manufacturer
Apotex Corp.
Effective date
2026-09-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nuvigil - Apotex Corp.Apotex Corp.2026-09-14HUMAN PRESCRIPTION DRUG LABEL
Nuvigil - Golden State Medical Supply, Inc.Golden State Medical Supply, Inc.2025-09-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-4849-3Nuvigil30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4849-3EA - Each60505-4849703b00cf-4ca6-43e0-b965-f475edae9d9312025-09-12

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 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
ArmodafinilARMODAFINILPreferred Pharmaceuticals Inc.93b9f9a4-66d9-4ed9-8f2f-903e416e900d2026-03-06Warnings, Adverse reactionsExact identifier
rxcui: 861960
unii: V63XWA605I
ArmodafinilARMODAFINILPreferred Pharmaceuticals Inc.4128759d-ed7c-4130-b24c-a0541f2b9e7f2026-03-06Warnings, Adverse reactionsExact identifier
rxcui: 724859
unii: V63XWA605I
ArmodafinilARMODAFINILBryant Ranch Prepack58e33a21-7816-4fa9-9fc7-c559426ad2b92026-02-04Warnings, Adverse reactionsExact identifier
rxcui: 724859
unii: V63XWA605I
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
NuvigilARMODAFINILGolden State Medical Supply, Inc.3dd49302-f757-d945-e063-6294a90afcba2025-09-02Warnings, Adverse reactionsExact identifier
application number: NDA021875
ndc (package): 60429-001-30
ndc (package): 60429-004-30
ndc (package): 60429-002-30
ndc (package): 60429-003-30
ndc (product): 60429-001
ndc (product): 60429-004
ndc (product): 60429-003
ndc (product): 60429-002
rxcui: 724863
rxcui: 724859
rxcui: 724861
rxcui: 861962
rxcui: 861960
rxcui: 805661
rxcui: 805659
rxcui: 805663
spl id: 3dd48c06-8784-6926-e063-6294a90a7590
spl set id: 3dd49302-f757-d945-e063-6294a90afcba
unii: V63XWA605I
ab761afd-b864-a5f9-e204-952c98103e63a69631d0-1263-769e-b232-4ab9160e0fa32025-08-18Warnings, Adverse reactionsExact identifier
spl id: ab761afd-b864-a5f9-e204-952c98103e63
spl set id: a69631d0-1263-769e-b232-4ab9160e0fa3
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
ARMODAFINILARMODAFINILDirectRxddd06dab-0855-5b4e-e053-2a95a90a5e672025-01-22Warnings, Adverse reactionsExact identifier
application number: NDA021875
rxcui: 861960
unii: V63XWA605I
ArmodafinilARMODAFINILDirect_Rxfacd329b-1925-61df-e053-6294a90ab7382025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 724863
unii: V63XWA605I
ARMODAFINILARMODAFINILdirect rxb1ba1cdd-cf57-7a8c-e053-2a95a90a2c192025-01-20Warnings, Adverse reactionsExact identifier
application number: NDA021875
rxcui: 724861
unii: V63XWA605I
ArmodafinilARMODAFINILQuality Care Products LLC98338994-7818-4b86-ae98-cd08fa7008792024-12-17Warnings, Adverse reactionsExact identifier
application number: NDA021875
rxcui: 724861
unii: V63XWA605I
ArmodafinilARMODAFINILBryant Ranch Prepackcbe7c0d9-dfd2-4000-bd76-7fe3454ce64f2024-04-03Warnings, Adverse reactionsExact identifier
rxcui: 724859
rxcui: 724861
unii: V63XWA605I
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
ArmodafinilARMODAFINILAurobindo Pharma Limited23da56b8-7552-4362-a1ab-e794c131194c2024-02-02Warnings, Adverse reactionsExact identifier
rxcui: 724863
rxcui: 724859
rxcui: 724861
rxcui: 861960
unii: V63XWA605I
ArmodafinilARMODAFINILNatco Pharma USA LLCde2f0921-e791-426c-9192-2b7162e2158c2023-12-05Warnings, Adverse reactionsExact identifier
rxcui: 724863
rxcui: 724859
rxcui: 724861
rxcui: 861960
unii: V63XWA605I
ArmodafinilARMODAFINILTeva Pharmaceuticals USA, Inc.b3cac300-c3d2-4189-a410-2aaf3773c0902023-01-31Warnings, Adverse reactionsExact identifier
application number: NDA021875
rxcui: 724863
rxcui: 724859
rxcui: 724861
rxcui: 861960
unii: V63XWA605I
ArmodafinilARMODAFINILSandoz Inca3341ec8-1ad4-49e2-922b-13d1b30c8c1d2023-01-31Warnings, Adverse reactionsExact identifier
application number: NDA021875
rxcui: 724863
rxcui: 724859
rxcui: 724861
rxcui: 861960
unii: V63XWA605I

Reported adverse events (FAERS/openFDA)#

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