FDA.reportPublic FDA data

Ramelteon

Product NDC
50268-822
11-digit product format
502680822
Labeler code
50268
Product ID
50268-822_5245f9f9-f98a-edbb-e063-6294a90ac184
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramelteon
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA215243
Marketing category
ANDA
Marketing start
2026-05-20
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
Ramelteon
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RAMELTEON8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii901AS54I69
Rxcui577348

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
50268-822-11Ramelteon1 in 1 BLISTER PACKTABLET12
50268-822-15Ramelteon50 in 1 BOXTABLET502

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577348ramelteon 8 MG Oral TabletPSN5245f9ee-b4ca-24b6-e063-6394a90a0b1b2
577348ramelteon 8 MG Oral TabletSCD5245f9ee-b4ca-24b6-e063-6394a90a0b1b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50268-822-11502680822111 in 1 BLISTER PACKHistorical
50268-822-155026808221550 BLISTER PACK in 1 BOX (50268-822-15) / 1 TABLET in 1 BLISTER PACK (50268-822-11) 50 blister pack2026-05-20NoNoCurrent