FDA.reportPublic FDA data

Ramelteon

Product NDC
50436-3980
11-digit product format
504363980
Labeler code
50436
Product ID
50436-3980_8825c625-8207-473f-acaa-594265e682d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramelteon
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA212650
Marketing category
ANDA
Marketing start
2020-06-30
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 conceptRelationVersionEffective
3a82c83c-9d80-697e-efb4-23e95bcb1bc2Product name820240809

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-3980-12024-01-30C16284748780-11030e365-0992-111a-e063-dadaa90a10e2These 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: 2005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-3980-1Ramelteon30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-3980-1EA - Each50436-398064472e2c-5957-4eda-94a5-e8e713c8831212022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-3980RAMELTEON TABLET, FILM COATED [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20221018_fdafa6f9-0872-48cc-9ed6-7c3f51b21411.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577348ramelteon 8 MG Oral TabletPSNfdafa6f9-0872-48cc-9ed6-7c3f51b214112
577348ramelteon 8 MG Oral TabletSCDfdafa6f9-0872-48cc-9ed6-7c3f51b214112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50436-3980-15043639800130 TABLET, FILM COATED in 1 BOTTLE (50436-3980-1) 2020-06-300000-00-00NoNoCurrent