ramelteon

Generic: ramelteon

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ramelteon
Generic Name ramelteon
Labeler asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ramelteon 8 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-628
Product ID 76420-628_0b2fcb56-d9fa-e9f6-e063-6294a90a2f8e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211567
Listing Expiration 2026-12-31
Marketing Start 2019-07-23

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 76420628
Hyphenated Format 76420-628

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 ANDA211567 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (76420-628-01)
  • 30 TABLET in 1 BOTTLE (76420-628-30)
  • 60 TABLET in 1 BOTTLE (76420-628-60)
  • 90 TABLET in 1 BOTTLE (76420-628-90)
source: ndc

Packages (4)

76420-628-01 100 TABLET in 1 BOTTLE (76420-628-01) 76420-628-30 30 TABLET in 1 BOTTLE (76420-628-30) 76420-628-60 60 TABLET in 1 BOTTLE (76420-628-60) 76420-628-90 90 TABLET in 1 BOTTLE (76420-628-90)

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": "0b2fcb56-d9fa-e9f6-e063-6294a90a2f8e", "openfda": {"nui": ["N0000175743", "N0000000250"], "unii": ["901AS54I69"], "rxcui": ["577348"], "spl_set_id": ["208dbac2-2634-4aff-8e2c-e5ecb47145e2"], "pharm_class_epc": ["Melatonin Receptor Agonist [EPC]"], "pharm_class_moa": ["Melatonin Receptor Agonists [MoA]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76420-628-01)", "package_ndc": "76420-628-01", "marketing_start_date": "20231017"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (76420-628-30)", "package_ndc": "76420-628-30", "marketing_start_date": "20231128"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (76420-628-60)", "package_ndc": "76420-628-60", "marketing_start_date": "20231128"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (76420-628-90)", "package_ndc": "76420-628-90", "marketing_start_date": "20231128"}], "brand_name": "Ramelteon", "product_id": "76420-628_0b2fcb56-d9fa-e9f6-e063-6294a90a2f8e", "dosage_form": "TABLET", "pharm_class": ["Melatonin Receptor Agonist [EPC]", "Melatonin Receptor Agonists [MoA]"], "product_ndc": "76420-628", "generic_name": "Ramelteon", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ramelteon", "active_ingredients": [{"name": "RAMELTEON", "strength": "8 mg/1"}], "application_number": "ANDA211567", "marketing_category": "ANDA", "marketing_start_date": "20190723", "listing_expiration_date": "20261231"}