FDA.reportPublic FDA data

Rozerem

Product NDC
64764-805
11-digit product format
647640805
Labeler code
64764
Product ID
64764-805_2021e7fb-108a-4783-9a37-8bc05bf28b28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ramelteon
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Takeda Pharmaceuticals America, Inc.
Application
NDA021782
Marketing category
NDA
Marketing start
2005-07-22
Substance
RAMELTEON
Active strength
8 mg/1
Pharmacologic classes
Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rozerem
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RAMELTEON8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii901AS54I69
Rxcui577348, 603162

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a82c83c-9d80-697e-efb4-23e95bcb1bc2Product name820240809

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64764-805-10Rozerem100 in 1 BOTTLETABLET, FILM COATED10020
64764-805-22Rozerem6 in 1 TRAYTABLET, FILM COATED620
64764-805-22Rozerem1 in 1 CARTONTABLET, FILM COATED120
64764-805-30Rozerem30 in 1 BOTTLETABLET, FILM COATED3020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64764-805-10EA - Each64764-805cb8b588c-678d-49df-9582-6b27e7b828f212012-07-24
64764-805-30EA - Each64764-8059e37ff3f-f5e2-4c91-9e34-e4d5e88fb11212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ramelteonACTIVE INGREDIENT901AS54I69ROZEREM (RAMELTEON) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]10
ramelteonACTIVE MOIETY901AS54I69ROZEREM (RAMELTEON) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]10
ramelteonACTIVE INGREDIENT901AS54I69ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
RAMELTEONACTIVE INGREDIENT901AS54I69ROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
RAMELTEONACTIVE MOIETY901AS54I69ROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
ramelteonACTIVE MOIETY901AS54I69ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
copovidoneINACTIVE INGREDIENTD9C330MD8BROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
polyethylene glycol 8000INACTIVE INGREDIENTQ662QK8M3BROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SHELLACINACTIVE INGREDIENT46N107B71OROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
shellacINACTIVE INGREDIENT46N107B71OROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
starch, cornINACTIVE INGREDIENTO8232NY3SJROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64764-805ROZEREM (RAMELTEON) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]17Current NDC, Legacy NDC, 4 package rows20230106_9de82310-70e8-47b9-b1fc-6c6848b99455.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577348ramelteon 8 MG Oral TabletPSN9de82310-70e8-47b9-b1fc-6c6848b9945520
603162Rozerem 8 MG Oral TabletPSN9de82310-70e8-47b9-b1fc-6c6848b9945520
603162ramelteon 8 MG Oral Tablet [Rozerem]SBD9de82310-70e8-47b9-b1fc-6c6848b9945520
577348ramelteon 8 MG Oral TabletSCD9de82310-70e8-47b9-b1fc-6c6848b9945520
603162Rozerem 8 MG Oral TabletSY9de82310-70e8-47b9-b1fc-6c6848b9945520
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
577348ramelteon 8 MG Oral TabletPSN7a51d289-2013-4d37-adf2-91ea49df79321
577348ramelteon 8 MG Oral TabletPSN3740dcc6-9ee8-4187-9112-6320500432401
603162Rozerem 8 MG Oral TabletPSN7a51d289-2013-4d37-adf2-91ea49df79321
603162Rozerem 8 MG Oral TabletPSN3740dcc6-9ee8-4187-9112-6320500432401
603162ramelteon 8 MG Oral Tablet [Rozerem]SBD7a51d289-2013-4d37-adf2-91ea49df79321
603162ramelteon 8 MG Oral Tablet [Rozerem]SBD3740dcc6-9ee8-4187-9112-6320500432401
577348ramelteon 8 MG Oral TabletSCD7a51d289-2013-4d37-adf2-91ea49df79321
577348ramelteon 8 MG Oral TabletSCD3740dcc6-9ee8-4187-9112-6320500432401
603162Rozerem 8 MG Oral TabletSY7a51d289-2013-4d37-adf2-91ea49df79321
603162Rozerem 8 MG Oral TabletSY3740dcc6-9ee8-4187-9112-6320500432401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64764-805-1064764080510100 TABLET, FILM COATED in 1 BOTTLE (64764-805-10) 2005-07-220000-00-00NoNoCurrent
64764-805-22647640805226 CARTON in 1 TRAY (64764-805-22) > 1 BLISTER PACK in 1 CARTON > 2 TABLET, FILM COATED in 1 BLISTER PACK6 carton2005-07-220000-00-00NoNoCurrent
64764-805-306476408053030 TABLET, FILM COATED in 1 BOTTLE (64764-805-30) 2005-07-220000-00-00NoNoCurrent