ramelteon

Generic: ramelteon

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ramelteon 8 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-708
Product ID 50268-708_3a9a3e15-b992-ab32-e063-6294a90aab3b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091693
Marketing Start 2021-01-06
Marketing End 2026-07-09

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 50268708
Hyphenated Format 50268-708

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 ANDA091693 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-708-15) / 1 TABLET in 1 BLISTER PACK (50268-708-11)
source: ndc

Packages (1)

50268-708-15 50 BLISTER PACK in 1 BOX (50268-708-15) / 1 TABLET in 1 BLISTER PACK (50268-708-11)

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": "3a9a3e15-b992-ab32-e063-6294a90aab3b", "openfda": {"nui": ["N0000175743", "N0000000250"], "unii": ["901AS54I69"], "rxcui": ["577348"], "spl_set_id": ["b83cb374-8b38-1e35-e053-2995a90aa527"], "pharm_class_epc": ["Melatonin Receptor Agonist [EPC]"], "pharm_class_moa": ["Melatonin Receptor Agonists [MoA]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-708-15)  / 1 TABLET in 1 BLISTER PACK (50268-708-11)", "package_ndc": "50268-708-15", "marketing_end_date": "20260709", "marketing_start_date": "20210106"}], "brand_name": "Ramelteon", "product_id": "50268-708_3a9a3e15-b992-ab32-e063-6294a90aab3b", "dosage_form": "TABLET", "pharm_class": ["Melatonin Receptor Agonist [EPC]", "Melatonin Receptor Agonists [MoA]"], "product_ndc": "50268-708", "generic_name": "Ramelteon", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ramelteon", "active_ingredients": [{"name": "RAMELTEON", "strength": "8 mg/1"}], "application_number": "ANDA091693", "marketing_category": "ANDA", "marketing_end_date": "20260709", "marketing_start_date": "20210106"}