ramelteon

Generic: ramelteon

Labeler: i3 pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ramelteon
Generic Name ramelteon
Labeler i3 pharmaceuticals, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ramelteon 8 mg/1

Manufacturer
i3 Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 72319-005
Product ID 72319-005_06e9fbb6-77c8-997b-e063-6394a90ad4f3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212650
Listing Expiration 2026-12-31
Marketing Start 2020-04-30

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 72319005
Hyphenated Format 72319-005

Supplemental Identifiers

RxCUI
577348
UPC
0372319005046 0372319005053 0372319005015
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
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72319-005-01)
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72319-005-04)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72319-005-05)
source: ndc

Packages (3)

72319-005-01 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72319-005-01) 72319-005-04 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72319-005-04) 72319-005-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72319-005-05)

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": "06e9fbb6-77c8-997b-e063-6394a90ad4f3", "openfda": {"nui": ["N0000175743", "N0000000250"], "upc": ["0372319005046", "0372319005053", "0372319005015"], "unii": ["901AS54I69"], "rxcui": ["577348"], "spl_set_id": ["32c52e03-4c2e-4774-9397-f1f0ee99b320"], "pharm_class_epc": ["Melatonin Receptor Agonist [EPC]"], "pharm_class_moa": ["Melatonin Receptor Agonists [MoA]"], "manufacturer_name": ["i3 Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72319-005-01)", "package_ndc": "72319-005-01", "marketing_start_date": "20200430"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72319-005-04)", "package_ndc": "72319-005-04", "marketing_start_date": "20200430"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72319-005-05)", "package_ndc": "72319-005-05", "marketing_start_date": "20200430"}], "brand_name": "Ramelteon", "product_id": "72319-005_06e9fbb6-77c8-997b-e063-6394a90ad4f3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Melatonin Receptor Agonist [EPC]", "Melatonin Receptor Agonists [MoA]"], "product_ndc": "72319-005", "generic_name": "Ramelteon", "labeler_name": "i3 Pharmaceuticals, 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": "20200430", "listing_expiration_date": "20261231"}