NDC 63459-0201 - PROVIGIL

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: 63459-0201
Manufacturer: Rebel Distributors Corp
Effective date: 2010-12-27
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
PROVIGIL - Rebel Distributors Corp	Rebel Distributors Corp	2010-12-27	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MODAFINIL	ACTIVE INGREDIENT	R3UK8X3U3D	PROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]	1
MODAFINIL	ACTIVE MOIETY	R3UK8X3U3D	PROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]	1

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 · 119 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Modafinil	MODAFINIL	Viona Pharmaceuticals Inc	15739a31-2433-49b5-90ea-b974214f73be	2023-11-10	Warnings, Adverse reactions	Exact identifier rxcui: 205324 rxcui: 260218 unii: R3UK8X3U3D
Allergies	APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM	Newton Laboratories, Inc.	0631d5e5-9da4-bcb7-e063-6394a90a62de	2023-09-25	Warnings	Exact identifier unii: J2B2A4N98G
Allergies	APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM	Newton Laboratories, Inc.	017f3bcf-0e45-d390-e063-6394a90a588e	2023-07-28	Warnings	Exact identifier unii: J2B2A4N98G
Allergies	APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM	Newton Laboratories, Inc.	017f0210-195d-11d7-e063-6294a90aa750	2023-07-27	Warnings	Exact identifier unii: J2B2A4N98G
Modafinil	MODAFINIL	Bionpharma Inc.	63604fef-0b80-40ce-8dbf-3384f1aee395	2023-07-21	Warnings, Adverse reactions	Exact identifier rxcui: 205324 rxcui: 260218 unii: R3UK8X3U3D
Modafinil	MODAFINIL	Proficient Rx LP	d97684d7-c236-451e-99bd-b8df4bf36643	2023-06-01	Warnings, Adverse reactions	Exact identifier rxcui: 205324 unii: R3UK8X3U3D
Modafinil	MODAFINIL	CIMA LABS INC.	9f3b0bd2-72a3-411f-aeec-b533373f1a97	2023-01-31	Warnings, Adverse reactions	Exact identifier application number: NDA020717 rxcui: 205324 rxcui: 260218 unii: R3UK8X3U3D
Modafinil	MODAFINIL	Aphena Pharma Solutions - Tennessee, LLC	a4a27496-0f5a-4ea8-b48c-72fcb323dc8f	2023-01-16	Warnings, Adverse reactions	Exact identifier rxcui: 205324 unii: R3UK8X3U3D
Allermilk	TARAXACUM OFFICINALE, HYDRASTIS CANADENSIS, BENZOICUM ACIDUM, CHOLINUM, CINNAMIC ACID, EUGENOL, FOLIC ACID, HISTAMINUM HYDROCHLORICUM, L-ASPARAGINE (MONOHYDRATE), MENADIONE, OOPHORINUM (SUIS), PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, QUERCETIN, RUTIN, SACCHARUM LACTIS, TYRAMINE, XANTHINE, COUMARINUM, FOLLICULINUM, FORMALINUM, GABA (GAMMA-AMINOBUTYRIC ACID), VANILLYLAMINE, APIOLUM	Deseret Biologicals, Inc.	c13cbfb9-1c1f-43b5-b218-e58c3c521f93	2023-01-12	Warnings	Exact identifier unii: J2B2A4N98G
Modafinil	MODAFINIL	Proficient Rx LP	ccf7836d-c131-4e7d-a339-fbf99fe7f449	2023-01-01	Warnings, Adverse reactions	Exact identifier rxcui: 260218 unii: R3UK8X3U3D
Provigil	MODAFINIL	Cephalon, LLC	e16c26ad-7bc2-d155-3a5d-da83ad6492c8	2022-12-31	Warnings, Adverse reactions	Exact identifier application number: NDA020717 ndc (product): 63459-101 rxcui: 226426 rxcui: 205324 rxcui: 260218 rxcui: 213471 unii: R3UK8X3U3D
Saccharum Lactis	SACCHARUM LACTIS	Hahnemann Laboratories, INC.	e6f02163-2845-680d-e053-2a95a90ae43a	2022-08-23		Exact identifier unii: J2B2A4N98G
Modafinil	MODAFINIL	Alembic Pharmaceuticals Limited	5b8496fe-b647-4ce6-aeef-71245712e46f	2022-06-03	Warnings, Adverse reactions	Exact identifier rxcui: 205324 rxcui: 260218 unii: R3UK8X3U3D
Modafinil	MODAFINIL	Alembic Pharmaceuticals Inc.	41f9ddbd-5228-4f0c-b0aa-2056af79a21e	2021-10-01	Warnings, Adverse reactions	Exact identifier rxcui: 205324 rxcui: 260218 unii: R3UK8X3U3D
Food Additives	IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,	Newton Laboratories, Inc.	9a61f1ae-d3a4-68d7-e053-2a95a90a4333	2020-12-03	Warnings	Exact identifier unii: J2B2A4N98G
Food Additives	IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,	Newton Laboratories, Inc.	9aefc830-329c-5e35-e053-2a95a90a6ffe	2020-11-30	Warnings	Exact identifier unii: J2B2A4N98G
Food Additives	IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,	Newton Laboratories, Inc.	9af2d6f4-baa8-5da9-e053-2995a90a3dac	2020-11-30	Warnings	Exact identifier unii: J2B2A4N98G
modafinil	MODAFINIL	Aphena Pharma Solutions - Tennessee, LLC	cad4201c-133c-4a61-9d93-3c5e51695430	2017-12-19	Warnings, Adverse reactions	Exact identifier application number: NDA020717 rxcui: 205324 unii: R3UK8X3U3D
8b79d52e-e6e5-4aaf-8835-242c72d6ee38			8b79d52e-e6e5-4aaf-8835-242c72d6ee38	2010-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier spl id: 8b79d52e-e6e5-4aaf-8835-242c72d6ee38 spl set id: 8b79d52e-e6e5-4aaf-8835-242c72d6ee38

Reported adverse events (FAERS/openFDA)#

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