Modafinil

Product NDC: 57237-154
11-digit product format: 572370154
Labeler code: 57237
Product ID: 57237-154_2f270ddd-1b6f-40bf-bfdc-c3f47f716dd1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Modafinil
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA202566
Marketing category: ANDA
Marketing start: 2012-09-27
Substance: MODAFINIL
Active strength: 100 mg/1
Pharmacologic classes: Central Nervous System Stimulation [PE], Increased Sympathetic Activity [PE], Sympathomimetic-like Agent [EPC]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
MODAFINIL	100 mg/1

Field, Values table
Field	Values
Unii	R3UK8X3U3D
Rxcui	205324, 260218

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57237-154-01	Modafinil	100 in 1 BOTTLE	TABLET	100	6
57237-154-30	Modafinil	30 in 1 BOTTLE	TABLET	30	6
57237-154-90	Modafinil	90 in 1 BOTTLE	TABLET	90	6

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-154-30	EA - Each	57237-154	715285dc-e881-4f57-b340-474f0f4296a2	1	2016-01-13
57237-154-90	EA - Each	57237-154	2ef025cc-0270-4737-a0dc-d0b3decf06cc	1	2016-01-13

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MODAFINIL	ACTIVE INGREDIENT	R3UK8X3U3D	MODAFINIL TABLET [CITRON PHARMA LLC]	1
MODAFINIL	ACTIVE MOIETY	R3UK8X3U3D	MODAFINIL TABLET [CITRON PHARMA LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MODAFINIL TABLET [CITRON PHARMA LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MODAFINIL TABLET [CITRON PHARMA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MODAFINIL TABLET [CITRON PHARMA LLC]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	MODAFINIL TABLET [CITRON PHARMA LLC]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-154	MODAFINIL TABLET [RISING PHARMA HOLDINGS, INC.]	6	Current NDC, Legacy NDC, 3 package rows	20240531_4b63aac6-4385-44a3-8390-cdbb0b4b5fe0.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
260218	modafinil 100 MG Oral Tablet	PSN	f1ff7c6d-df04-48dd-a971-454d38e7d997	8
260218	modafinil 100 MG Oral Tablet	SCD	f1ff7c6d-df04-48dd-a971-454d38e7d997	8
260218	modafinil 100 MG Oral Tablet	PSN	4b63aac6-4385-44a3-8390-cdbb0b4b5fe0	6
205324	modafinil 200 MG Oral Tablet	PSN	4b63aac6-4385-44a3-8390-cdbb0b4b5fe0	6
260218	modafinil 100 MG Oral Tablet	SCD	4b63aac6-4385-44a3-8390-cdbb0b4b5fe0	6
205324	modafinil 200 MG Oral Tablet	SCD	4b63aac6-4385-44a3-8390-cdbb0b4b5fe0	6
260218	modafinil 100 MG Oral Tablet	PSN	98e54b10-8ae0-7c43-e053-2a95a90ae8bb	3
260218	modafinil 100 MG Oral Tablet	SCD	98e54b10-8ae0-7c43-e053-2a95a90ae8bb	3
260218	modafinil 100 MG Oral Tablet	PSN	ccf7836d-c131-4e7d-a339-fbf99fe7f449	2
260218	modafinil 100 MG Oral Tablet	SCD	ccf7836d-c131-4e7d-a339-fbf99fe7f449	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57237-154-01	57237015401	100 TABLET in 1 BOTTLE (57237-154-01)	100 tablet	2012-09-27	0000-00-00	No	No	Current
57237-154-30	57237015430	30 TABLET in 1 BOTTLE (57237-154-30)	30 tablet	2012-09-27	0000-00-00	No	No	Current
57237-154-90	57237015490	90 TABLET in 1 BOTTLE (57237-154-90)	90 tablet	2012-09-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Modafinil	Bryant Ranch Prepack	2024-07-09	HUMAN PRESCRIPTION DRUG LABEL	8
Modafinil	NuCare Pharmaceuticals,Inc.	2024-06-20	HUMAN PRESCRIPTION DRUG LABEL	3
Modafinil	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2024-05-27	Human Prescription Drug Label	6
Modafinil	Proficient Rx LP	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	2