Ramelteon

Product NDC: 63629-8264
11-digit product format: 636298264
Labeler code: 63629
Product ID: 63629-8264_e953b8e0-4a70-4e7b-84d1-e6cc6cce4afb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ramelteon
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA091610
Marketing category: ANDA
Marketing start: 2019-07-22
Marketing end: 0000-00-00
Substance: RAMELTEON
Active strength: 8 mg/1
Pharmacologic classes: Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3a82c83c-9d80-697e-efb4-23e95bcb1bc2	Product name	8	20240809

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-8264-1	2024-01-30	C162847	48780-1	1030e365-25e1-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS . RAMELTEON tablets, for oral use Initial U.S. Approval: 200 5
63629-8264-2	2024-01-30	C162847	48780-1	1030e365-25e1-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS . RAMELTEON tablets, for oral use Initial U.S. Approval: 200 5

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-8264-1	Ramelteon	30 in 1 BOTTLE	TABLET	30		2
63629-8264-2	Ramelteon	60 in 1 BOTTLE	TABLET	60		2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8264	RAMELTEON TABLET [BRYANT RANCH PREPACK]	2	Legacy NDC, 2 package rows	20220507_13b7eab3-05af-42a8-a4a0-a9ace7004632.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
901AS54I69	RAMELTEON	196597-26-9	RAMELTEON

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
577348	ramelteon 8 MG Oral Tablet	PSN	13b7eab3-05af-42a8-a4a0-a9ace7004632	2
577348	ramelteon 8 MG Oral Tablet	SCD	13b7eab3-05af-42a8-a4a0-a9ace7004632	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8264-1	63629826401	30 TABLET in 1 BOTTLE (63629-8264-1)	30 tablet	2019-07-22	0000-00-00	No	No	Current
63629-8264-2	63629826402	60 TABLET in 1 BOTTLE (63629-8264-2)	60 tablet	2022-04-29	0000-00-00	No	No	Current