ramelteon

Generic: ramelteon

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ramelteon
Generic Name ramelteon
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ramelteon 8 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0343
Product ID 80425-0343_2a9bf7d3-46de-0dfa-e063-6394a90a76a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213815
Listing Expiration 2026-12-31
Marketing Start 2023-06-15

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 804250343
Hyphenated Format 80425-0343

Supplemental Identifiers

RxCUI
577348
UNII
901AS54I69
NUI
N0000175743 N0000000250

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 ANDA213815 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (80425-0343-1)
source: ndc

Packages (1)

80425-0343-1 30 TABLET, FILM COATED in 1 BOTTLE (80425-0343-1)

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": "2a9bf7d3-46de-0dfa-e063-6394a90a76a4", "openfda": {"nui": ["N0000175743", "N0000000250"], "unii": ["901AS54I69"], "rxcui": ["577348"], "spl_set_id": ["fe2fc3b7-4600-c14e-e053-6394a90a2586"], "pharm_class_epc": ["Melatonin Receptor Agonist [EPC]"], "pharm_class_moa": ["Melatonin Receptor Agonists [MoA]"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (80425-0343-1)", "package_ndc": "80425-0343-1", "marketing_start_date": "20230615"}], "brand_name": "Ramelteon", "product_id": "80425-0343_2a9bf7d3-46de-0dfa-e063-6394a90a76a4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Melatonin Receptor Agonist [EPC]", "Melatonin Receptor Agonists [MoA]"], "product_ndc": "80425-0343", "generic_name": "Ramelteon", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ramelteon", "active_ingredients": [{"name": "RAMELTEON", "strength": "8 mg/1"}], "application_number": "ANDA213815", "marketing_category": "ANDA", "marketing_start_date": "20230615", "listing_expiration_date": "20261231"}