ramelteon

Generic: ramelteon

Labeler: quality care products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ramelteon
Generic Name ramelteon
Labeler quality care products, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ramelteon 8 mg/1

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 55700-874
Product ID 55700-874_2851fcc0-042d-482d-bf42-1a81a9baaa38
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212650
Marketing Start 2020-07-28
Marketing End 2026-05-31

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 55700874
Hyphenated Format 55700-874

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 ANDA212650 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-874-30)
source: ndc

Packages (1)

55700-874-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-874-30)

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": "2851fcc0-042d-482d-bf42-1a81a9baaa38", "openfda": {"nui": ["N0000175743", "N0000000250"], "unii": ["901AS54I69"], "rxcui": ["577348"], "spl_set_id": ["316b5aa6-46dd-4808-b30d-b36fc730adbc"], "pharm_class_epc": ["Melatonin Receptor Agonist [EPC]"], "pharm_class_moa": ["Melatonin Receptor Agonists [MoA]"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-874-30)", "package_ndc": "55700-874-30", "marketing_end_date": "20260531", "marketing_start_date": "20200728"}], "brand_name": "Ramelteon", "product_id": "55700-874_2851fcc0-042d-482d-bf42-1a81a9baaa38", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Melatonin Receptor Agonist [EPC]", "Melatonin Receptor Agonists [MoA]"], "product_ndc": "55700-874", "generic_name": "Ramelteon", "labeler_name": "Quality Care Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ramelteon", "active_ingredients": [{"name": "RAMELTEON", "strength": "8 mg/1"}], "application_number": "ANDA212650", "marketing_category": "ANDA", "marketing_end_date": "20260531", "marketing_start_date": "20200728"}