ramelteon

Generic: ramelteon

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ramelteon
Generic Name ramelteon
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ramelteon 8 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7494
Product ID 0904-7494_44be28b2-f079-40ce-b86d-8b60eda1a7c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211567
Listing Expiration 2026-12-31
Marketing Start 2025-01-10

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 09047494
Hyphenated Format 0904-7494

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
  • 50 BLISTER PACK in 1 CARTON (0904-7494-06) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7494-06 50 BLISTER PACK in 1 CARTON (0904-7494-06) / 1 TABLET in 1 BLISTER PACK

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": "44be28b2-f079-40ce-b86d-8b60eda1a7c0", "openfda": {"nui": ["N0000175743", "N0000000250"], "unii": ["901AS54I69"], "rxcui": ["577348"], "spl_set_id": ["44be28b2-f079-40ce-b86d-8b60eda1a7c0"], "pharm_class_epc": ["Melatonin Receptor Agonist [EPC]"], "pharm_class_moa": ["Melatonin Receptor Agonists [MoA]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 CARTON (0904-7494-06)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-7494-06", "marketing_start_date": "20250110"}], "brand_name": "Ramelteon", "product_id": "0904-7494_44be28b2-f079-40ce-b86d-8b60eda1a7c0", "dosage_form": "TABLET", "pharm_class": ["Melatonin Receptor Agonist [EPC]", "Melatonin Receptor Agonists [MoA]"], "product_ndc": "0904-7494", "generic_name": "Ramelteon", "labeler_name": "Major Pharmaceuticals", "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": "20250110", "listing_expiration_date": "20261231"}