FDA.reportPublic FDA data

Ramelteon

Product NDC
71335-2186
11-digit product format
713352186
Labeler code
71335
Product ID
71335-2186_77709852-1778-45c5-8de9-d90820786d80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramelteon
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212650
Marketing category
ANDA
Marketing start
2020-06-30
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2186-1Ramelteon30 in 1 BOTTLE, PLASTICTABLET, FILM COATED30101
71335-2186-2Ramelteon60 in 1 BOTTLE, PLASTICTABLET, FILM COATED60101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2186-1EA - Each71335-2186e5db4a6f-147f-4f04-9bd8-6347332d276d12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2186RAMELTEON TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 2 package rows20231110_4d6ad234-69ae-4e33-824d-cff5d1500a86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577348ramelteon 8 MG Oral TabletPSN4d6ad234-69ae-4e33-824d-cff5d1500a86101
577348ramelteon 8 MG Oral TabletSCD4d6ad234-69ae-4e33-824d-cff5d1500a86101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2186-17133521860130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2186-1) 2022-11-040000-00-00NoNoCurrent
71335-2186-27133521860260 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2186-2) 2022-11-040000-00-00NoNoCurrent