NDC 0378-5575-01 - 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: 0378-5575
Requested NDC: 0378-5575-01
Package NDCs from labels: 0378-5575-93, 0378-5575-05, 0378-5575-01
Manufacturer: Mylan Institutional Inc.
Effective date: 2019-11-07
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Modafinil - Mylan Institutional Inc.	Mylan Institutional Inc.	2019-11-07	HUMAN PRESCRIPTION DRUG LABEL
Modafinil - Preferred Pharmaceuticals Inc.	Preferred Pharmaceuticals Inc.	2019-10-31	HUMAN PRESCRIPTION DRUG LABEL
Modafinil - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2016-03-17	HUMAN PRESCRIPTION DRUG LABEL
Modafinil - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2014-04-03	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2013-02-13	Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-5575-01	EA - Each	0378-5575	c1aa9f9a-3b66-4f85-a554-b2a0ea9a3399	1	2013-02-13
0378-5575-05	EA - Each	0378-5575	f12cf010-198e-40b0-b820-3eab9c75c678	1	2013-02-13
0378-5575-93	EA - Each	0378-5575	e79ed0aa-9321-4f3a-b19a-6a10905d27f0	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MODAFINIL	ACTIVE INGREDIENT	R3UK8X3U3D	MODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]	7
MODAFINIL	ACTIVE MOIETY	R3UK8X3U3D	MODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]	7
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	MODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]	7
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	MODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]	7
MODAFINIL	ACTIVE INGREDIENT	R3UK8X3U3D	MODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]	3
MODAFINIL	ACTIVE MOIETY	R3UK8X3U3D	MODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]	3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	MODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	MODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]	3
MODAFINIL	ACTIVE INGREDIENT	R3UK8X3U3D	MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
MODAFINIL	ACTIVE MOIETY	R3UK8X3U3D	MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	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 7 of 7 · 121 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
adec9b98-1867-41a0-9288-3185c095a6fc			514d242d-48c9-4162-a85a-a433b41107ac	2014-04-03	Warnings, Adverse reactions	Exact identifier spl id: adec9b98-1867-41a0-9288-3185c095a6fc spl set id: 514d242d-48c9-4162-a85a-a433b41107ac

Reported adverse events (FAERS/openFDA)#

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