ramelteon

Generic: ramelteon

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

Drug Facts

Product Profile

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

ramelteon 8 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-356
Product ID 69367-356_55698226-0017-4755-91f7-88aabc104172
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215435
Marketing Start 2023-09-08
Marketing End 2026-04-01

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 69367356
Hyphenated Format 69367-356

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 ANDA215435 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (69367-356-01)
  • 30 TABLET, COATED in 1 BOTTLE (69367-356-30)
source: ndc

Packages (2)

69367-356-01 100 TABLET, COATED in 1 BOTTLE (69367-356-01) 69367-356-30 30 TABLET, COATED in 1 BOTTLE (69367-356-30)

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": "55698226-0017-4755-91f7-88aabc104172", "openfda": {"nui": ["N0000175743", "N0000000250"], "unii": ["901AS54I69"], "rxcui": ["577348"], "spl_set_id": ["7f19c83a-4da3-4bb1-aae9-db0ec29175b3"], "pharm_class_epc": ["Melatonin Receptor Agonist [EPC]"], "pharm_class_moa": ["Melatonin Receptor Agonists [MoA]"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (69367-356-01)", "package_ndc": "69367-356-01", "marketing_end_date": "20260401", "marketing_start_date": "20230908"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (69367-356-30)", "package_ndc": "69367-356-30", "marketing_end_date": "20260401", "marketing_start_date": "20230908"}], "brand_name": "Ramelteon", "product_id": "69367-356_55698226-0017-4755-91f7-88aabc104172", "dosage_form": "TABLET, COATED", "pharm_class": ["Melatonin Receptor Agonist [EPC]", "Melatonin Receptor Agonists [MoA]"], "product_ndc": "69367-356", "generic_name": "Ramelteon", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ramelteon", "active_ingredients": [{"name": "RAMELTEON", "strength": "8 mg/1"}], "application_number": "ANDA215435", "marketing_category": "ANDA", "marketing_end_date": "20260401", "marketing_start_date": "20230908"}