NDC 63459-220-07 - 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: 63459-220
Requested NDC: 63459-220-07
Package NDCs from labels: 63459-220-07, 63459-220-35, 63459-220-30
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63459-220-07	Nuvigil	7 in 1 BLISTER PACK	TABLET	7	32
63459-220-30	Nuvigil	30 in 1 BOTTLE	TABLET	30	32
63459-220-35	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
63459-220	NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, LLC]	32	Legacy NDC, 3 package rows	20250507_d878aed0-ddbf-8fa1-abf7-d3e480260845.zip

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

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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Armodafinil	ARMODAFINIL	Mylan Pharmaceuticals Inc.	de0799f7-7644-4057-a7da-75436f978c61	2018-09-17	Warnings, Adverse reactions	Exact identifier rxcui: 724863 rxcui: 724859 rxcui: 724861 unii: V63XWA605I

Reported adverse events (FAERS/openFDA)#

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