Ramelteon

Product NDC
55700-874
11-digit product format
557000874
Labeler code
55700
Product ID
55700-874_2851fcc0-042d-482d-bf42-1a81a9baaa38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramelteon
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA212650
Marketing category
ANDA
Marketing start
2020-07-28
Marketing end
2026-05-31
Substance
RAMELTEON
Active strength
8 mg/1
Pharmacologic classes
Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

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
55700-874-30Ramelteon30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-874-30EA - Each55700-874e3df4c9b-9cd2-42f9-8981-5d3b98bf99b312020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-874RAMELTEON TABLET, FILM COATED [QUALITY CARE PRODUCTS, LLC]3Current NDC, Legacy NDC, 1 package rows20241220_316b5aa6-46dd-4808-b30d-b36fc730adbc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-874-305570008743030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-874-30) 2020-07-282026-05-31NoNoCurrent