FDA.reportPublic FDA data

Ramelteon

Product NDC
72319-005
11-digit product format
723190005
Labeler code
72319
Product ID
72319-005_06e9fbb6-77c8-997b-e063-6394a90ad4f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramelteon
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
i3 Pharmaceuticals, LLC
Application
ANDA212650
Marketing category
ANDA
Marketing start
2020-04-30
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
72319-005-01Ramelteon30 in 1 BOTTLE, PLASTICTABLET, FILM COATED306
72319-005-04Ramelteon100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1006
72319-005-05Ramelteon500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72319-005RAMELTEON TABLET, FILM COATED [I3 PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 3 package rows20231005_32c52e03-4c2e-4774-9397-f1f0ee99b320.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577348ramelteon 8 MG Oral TabletPSN32c52e03-4c2e-4774-9397-f1f0ee99b3206
577348ramelteon 8 MG Oral TabletSCD32c52e03-4c2e-4774-9397-f1f0ee99b3206

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72319-005-017231900050130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72319-005-01) 2020-04-300000-00-00NoNoCurrent
72319-005-0472319000504100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72319-005-04) 2020-04-300000-00-00NoNoCurrent
72319-005-0572319000505500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72319-005-05) 2020-04-300000-00-00NoNoCurrent