ramelteon

Generic: ramelteon

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ramelteon
Generic Name ramelteon
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ramelteon 8 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-505
Product ID 59651-505_ce8a4cd3-6dd1-48aa-a01b-cf08bda57ebb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215972
Listing Expiration 2026-12-31
Marketing Start 2023-07-10

Pharmacologic Class

Established (EPC)
melatonin receptor agonist [epc]
Mechanism of Action
melatonin receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651505
Hyphenated Format 59651-505

Supplemental Identifiers

RxCUI
577348
UNII
901AS54I69
NUI
N0000175743 N0000000250

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ramelteon (source: ndc)
Generic Name ramelteon (source: ndc)
Application Number ANDA215972 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (59651-505-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (59651-505-30)
source: ndc

Packages (2)

59651-505-01 100 TABLET, FILM COATED in 1 BOTTLE (59651-505-01) 59651-505-30 30 TABLET, FILM COATED in 1 BOTTLE (59651-505-30)

Ingredients (1)

ramelteon (8 mg/1)

Linked Drug Pages (1)

RAMELTEON ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ce8a4cd3-6dd1-48aa-a01b-cf08bda57ebb", "openfda": {"nui": ["N0000175743", "N0000000250"], "unii": ["901AS54I69"], "rxcui": ["577348"], "spl_set_id": ["01dfc4c5-07d1-4dd7-a9ca-a94203b2e16d"], "pharm_class_epc": ["Melatonin Receptor Agonist [EPC]"], "pharm_class_moa": ["Melatonin Receptor Agonists [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (59651-505-01)", "package_ndc": "59651-505-01", "marketing_start_date": "20230710"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (59651-505-30)", "package_ndc": "59651-505-30", "marketing_start_date": "20230710"}], "brand_name": "RAMELTEON", "product_id": "59651-505_ce8a4cd3-6dd1-48aa-a01b-cf08bda57ebb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Melatonin Receptor Agonist [EPC]", "Melatonin Receptor Agonists [MoA]"], "product_ndc": "59651-505", "generic_name": "RAMELTEON", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RAMELTEON", "active_ingredients": [{"name": "RAMELTEON", "strength": "8 mg/1"}], "application_number": "ANDA215972", "marketing_category": "ANDA", "marketing_start_date": "20230710", "listing_expiration_date": "20261231"}