FDA.reportPublic FDA data

Ramelteon

Product NDC
70700-272
11-digit product format
707000272
Labeler code
70700
Product ID
70700-272_15d4da7a-2091-e84d-872c-57ef7141d813
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramelteon
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Xiromed, LLC
Application
ANDA216209
Marketing category
ANDA
Marketing start
2022-11-25
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
70700-272-05Ramelteon500 in 1 BOTTLETABLET, FILM COATED5007
70700-272-10Ramelteon100 in 1 BOTTLETABLET, FILM COATED1007
70700-272-30Ramelteon30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-272-05EA - Each70700-27294f84114-6d88-465a-941c-f1c712f4cb8112023-07-06
70700-272-10EA - Each70700-2723365e0d8-a760-4b45-8d72-f5cdb526d20f12023-07-06
70700-272-30EA - Each70700-2728d2e686e-f718-4533-98aa-62d650d2a19712023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-272RAMELTEON TABLET, FILM COATED [XIROMED, LLC]7Current NDC, 3 package rows20230810_5c1ba52a-8e7a-844a-6c48-d1c9bf9fff0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577348ramelteon 8 MG Oral TabletPSN5c1ba52a-8e7a-844a-6c48-d1c9bf9fff0e7
577348ramelteon 8 MG Oral TabletSCD5c1ba52a-8e7a-844a-6c48-d1c9bf9fff0e7
577348ramelteon 8 MG Oral TabletPSN229403c5-de9c-dc61-e063-6394a90a2a701
577348ramelteon 8 MG Oral TabletSCD229403c5-de9c-dc61-e063-6394a90a2a701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70700-272-0570700027205500 TABLET, FILM COATED in 1 BOTTLE (70700-272-05) 2022-11-25NoNoCurrent
70700-272-1070700027210100 TABLET, FILM COATED in 1 BOTTLE (70700-272-10) 2022-11-25NoNoCurrent
70700-272-307070002723030 TABLET, FILM COATED in 1 BOTTLE (70700-272-30) 2022-11-25NoNoCurrent