Rozerem

Product NDC
68151-4881
11-digit product format
681514881
Labeler code
68151
Product ID
68151-4881_36aa7694-87d7-416d-b9ea-10fc29ecea2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ramelteon
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA021782
Marketing category
NDA
Marketing start
2005-07-22
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
E
Listing certified through
2018-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-4881-1Rozerem1 in 1 BLISTER PACKTABLET, FILM COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-4881ROZEREM (RAMELTEON) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20171229_63823b05-b54b-4221-9be9-5865d9221ee1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577348ramelteon 8 MG Oral TabletPSN63823b05-b54b-4221-9be9-5865d9221ee12
603162Rozerem 8 MG Oral TabletPSN63823b05-b54b-4221-9be9-5865d9221ee12
603162ramelteon 8 MG Oral Tablet [Rozerem]SBD63823b05-b54b-4221-9be9-5865d9221ee12
577348ramelteon 8 MG Oral TabletSCD63823b05-b54b-4221-9be9-5865d9221ee12
603162Rozerem 8 MG Oral TabletSY63823b05-b54b-4221-9be9-5865d9221ee12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-4881-1681514881011 in 1 BLISTER PACKHistorical