ramelteon

Generic: ramelteon

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ramelteon
Generic Name ramelteon
Labeler actavis pharma, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ramelteon 8 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-2191
Product ID 0591-2191_181ea308-f62b-48a0-81fc-a4654d679adb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091610
Listing Expiration 2026-12-31
Marketing Start 2019-07-22

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 05912191
Hyphenated Format 0591-2191

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 ANDA091610 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0591-2191-01)
  • 30 TABLET in 1 BOTTLE (0591-2191-30)
source: ndc

Packages (2)

0591-2191-01 100 TABLET in 1 BOTTLE (0591-2191-01) 0591-2191-30 30 TABLET in 1 BOTTLE (0591-2191-30)

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": "181ea308-f62b-48a0-81fc-a4654d679adb", "openfda": {"nui": ["N0000175743", "N0000000250"], "unii": ["901AS54I69"], "rxcui": ["577348"], "spl_set_id": ["a89dae05-6c39-4072-b8ee-c4c35b46f7d4"], "pharm_class_epc": ["Melatonin Receptor Agonist [EPC]"], "pharm_class_moa": ["Melatonin Receptor Agonists [MoA]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0591-2191-01)", "package_ndc": "0591-2191-01", "marketing_start_date": "20190722"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (0591-2191-30)", "package_ndc": "0591-2191-30", "marketing_start_date": "20190722"}], "brand_name": "Ramelteon", "product_id": "0591-2191_181ea308-f62b-48a0-81fc-a4654d679adb", "dosage_form": "TABLET", "pharm_class": ["Melatonin Receptor Agonist [EPC]", "Melatonin Receptor Agonists [MoA]"], "product_ndc": "0591-2191", "generic_name": "Ramelteon", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ramelteon", "active_ingredients": [{"name": "RAMELTEON", "strength": "8 mg/1"}], "application_number": "ANDA091610", "marketing_category": "ANDA", "marketing_start_date": "20190722", "listing_expiration_date": "20261231"}