ramelteon

Generic: ramelteon

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ramelteon 8 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-776
Product ID 42291-776_4875af35-46c6-d9e6-e063-6394a90ab93d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213186
Listing Expiration 2027-12-31
Marketing Start 2020-12-21

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 42291776
Hyphenated Format 42291-776

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 ANDA213186 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (42291-776-30)
source: ndc

Packages (1)

42291-776-30 30 TABLET in 1 BOTTLE (42291-776-30)

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": "4875af35-46c6-d9e6-e063-6394a90ab93d", "openfda": {"nui": ["N0000175743", "N0000000250"], "unii": ["901AS54I69"], "rxcui": ["577348"], "spl_set_id": ["b6fc0db5-c68f-5af9-e053-2a95a90a5110"], "pharm_class_epc": ["Melatonin Receptor Agonist [EPC]"], "pharm_class_moa": ["Melatonin Receptor Agonists [MoA]"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (42291-776-30)", "package_ndc": "42291-776-30", "marketing_start_date": "20201221"}], "brand_name": "Ramelteon", "product_id": "42291-776_4875af35-46c6-d9e6-e063-6394a90ab93d", "dosage_form": "TABLET", "pharm_class": ["Melatonin Receptor Agonist [EPC]", "Melatonin Receptor Agonists [MoA]"], "product_ndc": "42291-776", "generic_name": "Ramelteon", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ramelteon", "active_ingredients": [{"name": "RAMELTEON", "strength": "8 mg/1"}], "application_number": "ANDA213186", "marketing_category": "ANDA", "marketing_start_date": "20201221", "listing_expiration_date": "20271231"}