ramelteon

Generic: ramelteon

Labeler: trupharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ramelteon
Generic Name ramelteon
Labeler trupharma, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ramelteon 8 mg/1

Manufacturer
TruPharma, LLC

Identifiers & Regulatory

Product NDC 52817-235
Product ID 52817-235_06ea67d8-b615-776b-e063-6294a90a3185
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212650
Listing Expiration 2026-12-31
Marketing Start 2020-06-30

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 52817235
Hyphenated Format 52817-235

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 ANDA212650 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52817-235-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52817-235-30)
source: ndc

Packages (2)

52817-235-10 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52817-235-10) 52817-235-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52817-235-30)

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": "06ea67d8-b615-776b-e063-6294a90a3185", "openfda": {"nui": ["N0000175743", "N0000000250"], "unii": ["901AS54I69"], "rxcui": ["577348"], "spl_set_id": ["3d0cc378-4bc5-425c-8f41-43eb734c24d9"], "pharm_class_epc": ["Melatonin Receptor Agonist [EPC]"], "pharm_class_moa": ["Melatonin Receptor Agonists [MoA]"], "manufacturer_name": ["TruPharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52817-235-10)", "package_ndc": "52817-235-10", "marketing_start_date": "20200630"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52817-235-30)", "package_ndc": "52817-235-30", "marketing_start_date": "20200630"}], "brand_name": "Ramelteon", "product_id": "52817-235_06ea67d8-b615-776b-e063-6294a90a3185", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Melatonin Receptor Agonist [EPC]", "Melatonin Receptor Agonists [MoA]"], "product_ndc": "52817-235", "generic_name": "Ramelteon", "labeler_name": "TruPharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ramelteon", "active_ingredients": [{"name": "RAMELTEON", "strength": "8 mg/1"}], "application_number": "ANDA212650", "marketing_category": "ANDA", "marketing_start_date": "20200630", "listing_expiration_date": "20261231"}