FDA.reportPublic FDA data

Ramelteon

Product NDC
71205-918
11-digit product format
712050918
Labeler code
71205
Product ID
71205-918_c90ef143-aff7-41d6-9171-3e5e7bb6e97e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramelteon
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA213186
Marketing category
ANDA
Marketing start
2020-10-01
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
71205-918-00Ramelteon100 in 1 BOTTLETABLET1003
71205-918-30Ramelteon30 in 1 BOTTLETABLET303
71205-918-55Ramelteon500 in 1 BOTTLETABLET5003
71205-918-60Ramelteon60 in 1 BOTTLETABLET603
71205-918-72Ramelteon120 in 1 BOTTLETABLET1203
71205-918-90Ramelteon90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-918-00EA - Each71205-9185473af88-218f-46ad-ac32-5f78d180609012021-08-05
71205-918-30EA - Each71205-91896334675-5659-4974-b89f-e29a5685114e12021-08-05
71205-918-55EA - Each71205-91869db0a14-421a-4090-88bc-04c3b8e8b93912021-08-05
71205-918-60EA - Each71205-918d4de6eb3-e7b7-470c-bb03-f9248139e6e912021-08-05
71205-918-72EA - Each71205-918a01d3263-0b3a-454f-8f64-a7fb3bd0b7c612021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-918RAMELTEON TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 6 package rows20220420_7ca849d3-f0ba-45b5-9aec-f4b7ea105fac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577348ramelteon 8 MG Oral TabletPSN7ca849d3-f0ba-45b5-9aec-f4b7ea105fac3
577348ramelteon 8 MG Oral TabletSCD7ca849d3-f0ba-45b5-9aec-f4b7ea105fac3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-918-0071205091800100 TABLET in 1 BOTTLE (71205-918-00) 100 tablet2021-07-070000-00-00NoNoCurrent
71205-918-307120509183030 TABLET in 1 BOTTLE (71205-918-30) 30 tablet2021-07-070000-00-00NoNoCurrent
71205-918-5571205091855500 TABLET in 1 BOTTLE (71205-918-55) 500 tablet2021-07-070000-00-00NoNoCurrent
71205-918-607120509186060 TABLET in 1 BOTTLE (71205-918-60) 60 tablet2021-07-070000-00-00NoNoCurrent
71205-918-7271205091872120 TABLET in 1 BOTTLE (71205-918-72) 120 tablet2021-07-070000-00-00NoNoCurrent
71205-918-907120509189090 TABLET in 1 BOTTLE (71205-918-90) 90 tablet2021-07-070000-00-00NoNoCurrent