ramelteon

Generic: ramelteon

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ramelteon
Generic Name ramelteon
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ramelteon 8 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-216
Product ID 82804-216_2cb1b48a-05c0-4058-8ccd-1971098b8ce1
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 82804216
Hyphenated Format 82804-216

Supplemental Identifiers

RxCUI
577348
UPC
0382804216307
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 ANDA212650 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-216-30)
source: ndc

Packages (1)

82804-216-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-216-30)

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": "2cb1b48a-05c0-4058-8ccd-1971098b8ce1", "openfda": {"nui": ["N0000175743", "N0000000250"], "upc": ["0382804216307"], "unii": ["901AS54I69"], "rxcui": ["577348"], "spl_set_id": ["2cb1b48a-05c0-4058-8ccd-1971098b8ce1"], "pharm_class_epc": ["Melatonin Receptor Agonist [EPC]"], "pharm_class_moa": ["Melatonin Receptor Agonists [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-216-30)", "package_ndc": "82804-216-30", "marketing_start_date": "20250417"}], "brand_name": "Ramelteon", "product_id": "82804-216_2cb1b48a-05c0-4058-8ccd-1971098b8ce1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Melatonin Receptor Agonist [EPC]", "Melatonin Receptor Agonists [MoA]"], "product_ndc": "82804-216", "generic_name": "Ramelteon", "labeler_name": "Proficient Rx LP", "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"}