Modafinil

Product NDC: 43353-956
11-digit product format: 433530956
Labeler code: 43353
Product ID: 43353-956_3e90688a-3561-4481-b232-978a4b33a46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Modafinil
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: NDA020717
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2012-04-06
Marketing end: 0000-00-00
Substance: MODAFINIL
Active strength: 200 mg/1
Pharmacologic classes: Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]
DEA schedule: CIV
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
91b7dea8-da1b-abb1-9750-2e680cd894b6	Product name	2	20171005

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43353-956-30	2020-01-31	C162847	48780-1	9d75b9d1-1c62-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use modafinil safely and effectively. See full prescribing information for modafinil. Modafinil tablets, for oral use, C-IV Initial U.S. Approval: 1998
43353-956-53	2020-01-31	C162847	48780-1	9d75b9d1-1c62-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use modafinil safely and effectively. See full prescribing information for modafinil. Modafinil tablets, for oral use, C-IV Initial U.S. Approval: 1998

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43353-956-30	Modafinil	30 in 1 BOTTLE	TABLET	30		1
43353-956-53	Modafinil	60 in 1 BOTTLE	TABLET	60		1

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-956-30	EA - Each	43353-956	c0c7c492-c015-4331-9a23-89e3ad893c4a	1	2016-07-19
43353-956-53	EA - Each	43353-956	46e7c85d-21db-4d10-a1c7-4c2a6c5a9f8a	1	2016-07-19

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-956	MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 2 package rows	20160713_6a8a2185-52f9-4952-a361-514e44b1cd44.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R3UK8X3U3D	MODAFINIL	68693-11-8	MODAFINIL

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
205324	modafinil 200 MG Oral Tablet	PSN	6a8a2185-52f9-4952-a361-514e44b1cd44	1
205324	modafinil 200 MG Oral Tablet	SCD	6a8a2185-52f9-4952-a361-514e44b1cd44	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-956-30	43353095630	30 in 1 BOTTLE	Historical
43353-956-53	43353095653	60 in 1 BOTTLE	Historical