FDA.reportPublic FDA data

Ramelteon

Product NDC
42571-375
11-digit product format
425710375
Labeler code
42571
Product ID
42571-375_336c8c9f-7af0-d608-e063-6394a90a5e21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramelteon
Dosage form
TABLET
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA215243
Marketing category
ANDA
Marketing start
2023-05-01
Substance
RAMELTEON
Active strength
8 mg/1
Pharmacologic classes
Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ramelteon
Listing expiration
2026-12-31

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
42571-375-01Ramelteon100 in 1 BOTTLETABLET1002
42571-375-05Ramelteon500 in 1 BOTTLETABLET5002
42571-375-30Ramelteon30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-375-01EA - Each42571-375b2b8f8f2-f1fd-4165-a5fd-7462ff6c26f712023-10-16
42571-375-30EA - Each42571-37506206768-b55d-4f40-8505-f07655d2246912023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-375RAMELTEON TABLET [MICRO LABS LIMITED]2Current NDC, 3 package rows20250424_7545c79a-93ea-4f73-beb5-cac46b2ed7e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577348ramelteon 8 MG Oral TabletPSN4c25cf94-f30e-4940-9f8b-3cb34258ba04100
577348ramelteon 8 MG Oral TabletSCD4c25cf94-f30e-4940-9f8b-3cb34258ba04100
577348ramelteon 8 MG Oral TabletPSN5245f9ee-b4ca-24b6-e063-6394a90a0b1b2
577348ramelteon 8 MG Oral TabletPSN7545c79a-93ea-4f73-beb5-cac46b2ed7e92
577348ramelteon 8 MG Oral TabletSCD5245f9ee-b4ca-24b6-e063-6394a90a0b1b2
577348ramelteon 8 MG Oral TabletSCD7545c79a-93ea-4f73-beb5-cac46b2ed7e92
577348ramelteon 8 MG Oral TabletPSNf15c8612-4065-4078-bff9-f2ffc13196541
577348ramelteon 8 MG Oral TabletSCDf15c8612-4065-4078-bff9-f2ffc13196541

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42571-375-0142571037501100 TABLET in 1 BOTTLE (42571-375-01) 100 tablet2023-05-01NoNoCurrent
42571-375-0542571037505500 TABLET in 1 BOTTLE (42571-375-05) 500 tablet2023-05-01NoNoCurrent
42571-375-304257103753030 TABLET in 1 BOTTLE (42571-375-30) 30 tablet2023-05-01NoNoCurrent