NDC 63459-225-07 - 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: 63459-225
Requested NDC: 63459-225-07
Package NDCs from labels: 63459-225-07, 63459-225-35, 63459-225-30
Manufacturer: Cephalon, LLC
Effective date: 2022-12-31
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Nuvigil - Cephalon, LLC	Cephalon, LLC	2022-12-31	HUMAN PRESCRIPTION DRUG LABEL
NUVIGIL ® (armodafinil) Tablets [C-IV]	STAT Rx USA LLC \| PSS World Medical Inc.	2012-10-08	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63459-225-07	Nuvigil	7 in 1 BLISTER PACK	TABLET	7	32
63459-225-30	Nuvigil	30 in 1 BOTTLE	TABLET	30	32
63459-225-35	Nuvigil	5 in 1 CARTON	TABLET	5	32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63459-225	NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, LLC]	32	Legacy NDC, 3 package rows	20250507_d878aed0-ddbf-8fa1-abf7-d3e480260845.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63459-225-30	EA - Each	63459-225	237e3089-bdcf-444a-8422-a268d8abfa40	1	2012-07-24
63459-225-60	EA - Each	63459-225	2259ae96-4c72-446f-9796-ecac197c58c3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ARMODAFINIL	ACTIVE INGREDIENT	V63XWA605I	NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]	16
ARMODAFINIL	ACTIVE MOIETY	V63XWA605I	NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]	16
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]	16
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]	16
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]	16
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]	16
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]	16
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, INCORPORATED]	16
ARMODAFINIL	ACTIVE INGREDIENT	V63XWA605I	NUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]	2
ARMODAFINIL	ACTIVE MOIETY	V63XWA605I	NUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NUVIGIL (ARMODAFINIL) TABLET [STAT RX USA LLC]	2

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 5 · 82 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pure Cornstarch Baby	CORN STARCH	Walgreen Company	d0e9bd13-b568-4f7e-b036-8d23e71ad8bf	2024-03-25	Warnings	Exact identifier unii: O8232NY3SJ
REFRESH CLASSIC	POLYVINYL ALCOHOL, POVIDONE	A-S Medication Solutions	3bf6193c-56db-45ad-844c-58eb8c33cba9	2024-03-14	Warnings	Exact identifier unii: FZ989GH94E
Armodafinil	ARMODAFINIL	Aurobindo Pharma Limited	23da56b8-7552-4362-a1ab-e794c131194c	2024-02-02	Warnings, Adverse reactions	Exact identifier rxcui: 724863 rxcui: 724859 rxcui: 724861 rxcui: 861960 unii: V63XWA605I
GOODSENSE ARTIFICIAL TEARS	POLYVINYL ALCOHOL	Proficient Rx LP	f29c792c-6cb2-449f-b97d-6304a58dec2a	2024-02-01	Warnings	Exact identifier unii: FZ989GH94E
GoodSense Artifical Tears	POLYVINYL ALCOHOL, AND POVIDONE	Proficient Rx LP	cd24da78-fd90-4a9c-8e5f-f7fc56ec0fc9	2024-02-01	Warnings	Exact identifier unii: FZ989GH94E
Sunmark Eye Drops Advanced Moisturizer/Lubricant	DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE	Strategic Sourcing Services LLC	0daa4e39-0447-44b6-a7d7-370b12bf9451	2023-12-23	Warnings	Exact identifier unii: FZ989GH94E
Meijer Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Meijer Distribution, Inc.	9feb3eec-a36f-8fc7-e053-2a95a90adcd3	2023-12-22	Warnings	Exact identifier unii: FZ989GH94E
Meijer Advanced Redness and Irritation Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI	Meijer Distribution, Inc.	9fea6d7a-a2cd-d26e-e053-2995a90a15f8	2023-12-22	Warnings	Exact identifier unii: FZ989GH94E
Walgreens Eye Drops Advanced Relief 15mL	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI	Walgreen Company	949f5560-fba7-2da8-e053-2995a90a23c2	2023-12-20	Warnings	Exact identifier unii: FZ989GH94E
Signature Care Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Better Living Brands LLC	5d7228ce-f108-4cc2-9aec-8b4548c3a155	2023-12-20	Warnings	Exact identifier unii: FZ989GH94E
Kroger Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Kroger Company	f7ad77fc-d890-25b9-e053-6394a90a2b12	2023-12-20	Warnings	Exact identifier unii: FZ989GH94E
Equaline Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	United Natural Foods, Inc.	f7602789-179a-edfc-e053-6294a90a0844	2023-12-20	Warnings	Exact identifier unii: FZ989GH94E
Topcare Health Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Topco Associates LLC	9c614c0e-5862-682f-e053-2a95a90abc09	2023-12-20	Warnings	Exact identifier unii: FZ989GH94E
TopCare Health Advanced Moisturizing Plus Redness Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Topco Associates LLC	9c6193a6-d822-1b27-e053-2995a90ab3cf	2023-12-20	Warnings	Exact identifier unii: FZ989GH94E
HEB Advanced Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	HEB Grocery Company, LP	f76281d6-3aea-349b-e053-6394a90afca2	2023-12-20	Warnings	Exact identifier unii: FZ989GH94E
Armodafinil	ARMODAFINIL	Natco Pharma USA LLC	de2f0921-e791-426c-9192-2b7162e2158c	2023-12-05	Warnings, Adverse reactions	Exact identifier rxcui: 724863 rxcui: 724859 rxcui: 724861 rxcui: 861960 unii: V63XWA605I
Good Neighbor Pharmacy Artifical Tears Lubricant Eye Drops	POLYVINYL ALCOHOL, POVIDONE	Proficient Rx LP	73e12596-6dd5-4cd2-83ed-992e1211b4b8	2023-12-01	Warnings	Exact identifier unii: FZ989GH94E
Armodafinil	ARMODAFINIL	Teva Pharmaceuticals USA, Inc.	b3cac300-c3d2-4189-a410-2aaf3773c090	2023-01-31	Warnings, Adverse reactions	Exact identifier application number: NDA021875 rxcui: 724863 rxcui: 724859 rxcui: 724861 rxcui: 861960 unii: V63XWA605I
Armodafinil	ARMODAFINIL	Sandoz Inc	a3341ec8-1ad4-49e2-922b-13d1b30c8c1d	2023-01-31	Warnings, Adverse reactions	Exact identifier application number: NDA021875 rxcui: 724863 rxcui: 724859 rxcui: 724861 rxcui: 861960 unii: V63XWA605I
Nuvigil	ARMODAFINIL	Cephalon, LLC	d878aed0-ddbf-8fa1-abf7-d3e480260845	2022-12-31	Warnings, Adverse reactions	Exact identifier application number: NDA021875 ndc (package): 63459-220-07 ndc (package): 63459-215-30 ndc (package): 63459-225-35 ndc (package): 63459-225-30 ndc (package): 63459-225-07 ndc (package): 63459-215-07 ndc (package): 63459-220-30 ndc (package): 63459-215-35 ndc (package): 63459-205-30 ndc (package): 63459-220-35 ndc (product): 63459-225 ndc (product): 63459-220 ndc (product): 63459-205 ndc (product): 63459-215 ndc11 (package): 63459022507 rxcui: 724863 rxcui: 724859 rxcui: 724861 rxcui: 861962 rxcui: 861960 rxcui: 805661 rxcui: 805659 rxcui: 805663 spl id: a70488d7-57ea-446e-89c2-87b0ecc90023 spl set id: d878aed0-ddbf-8fa1-abf7-d3e480260845 unii: V63XWA605I

Reported adverse events (FAERS/openFDA)#

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