ramelteon

Generic: ramelteon

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ramelteon
Generic Name ramelteon
Labeler micro labs limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ramelteon 8 mg/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-375
Product ID 42571-375_336c8c9f-7af0-d608-e063-6394a90a5e21
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215243
Listing Expiration 2026-12-31
Marketing Start 2023-05-01

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 42571375
Hyphenated Format 42571-375

Supplemental Identifiers

RxCUI
577348
UPC
0342571375300
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 ANDA215243 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (42571-375-01)
  • 500 TABLET in 1 BOTTLE (42571-375-05)
  • 30 TABLET in 1 BOTTLE (42571-375-30)
source: ndc

Packages (3)

42571-375-01 100 TABLET in 1 BOTTLE (42571-375-01) 42571-375-05 500 TABLET in 1 BOTTLE (42571-375-05) 42571-375-30 30 TABLET in 1 BOTTLE (42571-375-30)

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": "336c8c9f-7af0-d608-e063-6394a90a5e21", "openfda": {"nui": ["N0000175743", "N0000000250"], "upc": ["0342571375300"], "unii": ["901AS54I69"], "rxcui": ["577348"], "spl_set_id": ["7545c79a-93ea-4f73-beb5-cac46b2ed7e9"], "pharm_class_epc": ["Melatonin Receptor Agonist [EPC]"], "pharm_class_moa": ["Melatonin Receptor Agonists [MoA]"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42571-375-01)", "package_ndc": "42571-375-01", "marketing_start_date": "20230501"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (42571-375-05)", "package_ndc": "42571-375-05", "marketing_start_date": "20230501"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (42571-375-30)", "package_ndc": "42571-375-30", "marketing_start_date": "20230501"}], "brand_name": "Ramelteon", "product_id": "42571-375_336c8c9f-7af0-d608-e063-6394a90a5e21", "dosage_form": "TABLET", "pharm_class": ["Melatonin Receptor Agonist [EPC]", "Melatonin Receptor Agonists [MoA]"], "product_ndc": "42571-375", "generic_name": "Ramelteon", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ramelteon", "active_ingredients": [{"name": "RAMELTEON", "strength": "8 mg/1"}], "application_number": "ANDA215243", "marketing_category": "ANDA", "marketing_start_date": "20230501", "listing_expiration_date": "20261231"}