ramelteon

Generic: ramelteon

Labeler: dr.reddys laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ramelteon
Generic Name ramelteon
Labeler dr.reddys laboratories inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ramelteon 8 mg/1

Manufacturer
Dr.Reddys Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-741
Product ID 43598-741_54220029-c5df-b277-af7e-2786da03bbed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091693
Marketing Start 2019-07-22
Marketing End 2026-07-31

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 43598741
Hyphenated Format 43598-741

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 ANDA091693 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (43598-741-01)
  • 30 TABLET in 1 BOTTLE (43598-741-30)
source: ndc

Packages (2)

43598-741-01 100 TABLET in 1 BOTTLE (43598-741-01) 43598-741-30 30 TABLET in 1 BOTTLE (43598-741-30)

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": "54220029-c5df-b277-af7e-2786da03bbed", "openfda": {"nui": ["N0000175743", "N0000000250"], "unii": ["901AS54I69"], "rxcui": ["577348"], "spl_set_id": ["b71cd925-1bae-5a6a-072b-941ad6d3ce65"], "pharm_class_epc": ["Melatonin Receptor Agonist [EPC]"], "pharm_class_moa": ["Melatonin Receptor Agonists [MoA]"], "manufacturer_name": ["Dr.Reddys Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (43598-741-01)", "package_ndc": "43598-741-01", "marketing_end_date": "20260731", "marketing_start_date": "20190722"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (43598-741-30)", "package_ndc": "43598-741-30", "marketing_end_date": "20260709", "marketing_start_date": "20190722"}], "brand_name": "Ramelteon", "product_id": "43598-741_54220029-c5df-b277-af7e-2786da03bbed", "dosage_form": "TABLET", "pharm_class": ["Melatonin Receptor Agonist [EPC]", "Melatonin Receptor Agonists [MoA]"], "product_ndc": "43598-741", "generic_name": "Ramelteon", "labeler_name": "Dr.Reddys Laboratories Inc", "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": "20260731", "marketing_start_date": "20190722"}