rozerem

Generic: ramelteon

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name rozerem
Generic Name ramelteon
Labeler takeda pharmaceuticals america, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ramelteon 8 mg/1

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 64764-805
Product ID 64764-805_1896c6df-ae75-40ef-8b19-280b2d80cbe4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021782
Listing Expiration 2026-12-31
Marketing Start 2005-07-22

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 64764805
Hyphenated Format 64764-805

Supplemental Identifiers

RxCUI
577348 603162
UPC
0364764805302
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 rozerem (source: ndc)
Generic Name ramelteon (source: ndc)
Application Number NDA021782 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (64764-805-10)
  • 6 CARTON in 1 TRAY (64764-805-22) / 1 BLISTER PACK in 1 CARTON / 2 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (64764-805-30)
source: ndc

Packages (3)

64764-805-10 100 TABLET, FILM COATED in 1 BOTTLE (64764-805-10) 64764-805-22 6 CARTON in 1 TRAY (64764-805-22) / 1 BLISTER PACK in 1 CARTON / 2 TABLET, FILM COATED in 1 BLISTER PACK 64764-805-30 30 TABLET, FILM COATED in 1 BOTTLE (64764-805-30)

Ingredients (1)

ramelteon (8 mg/1)

Linked Drug Pages (1)

Rozerem ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1896c6df-ae75-40ef-8b19-280b2d80cbe4", "openfda": {"nui": ["N0000175743", "N0000000250"], "upc": ["0364764805302"], "unii": ["901AS54I69"], "rxcui": ["577348", "603162"], "spl_set_id": ["9de82310-70e8-47b9-b1fc-6c6848b99455"], "pharm_class_epc": ["Melatonin Receptor Agonist [EPC]"], "pharm_class_moa": ["Melatonin Receptor Agonists [MoA]"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (64764-805-10)", "package_ndc": "64764-805-10", "marketing_start_date": "20050722"}, {"sample": false, "description": "6 CARTON in 1 TRAY (64764-805-22)  / 1 BLISTER PACK in 1 CARTON / 2 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "64764-805-22", "marketing_start_date": "20050722"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (64764-805-30)", "package_ndc": "64764-805-30", "marketing_start_date": "20050722"}], "brand_name": "Rozerem", "product_id": "64764-805_1896c6df-ae75-40ef-8b19-280b2d80cbe4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Melatonin Receptor Agonist [EPC]", "Melatonin Receptor Agonists [MoA]"], "product_ndc": "64764-805", "generic_name": "ramelteon", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rozerem", "active_ingredients": [{"name": "RAMELTEON", "strength": "8 mg/1"}], "application_number": "NDA021782", "marketing_category": "NDA", "marketing_start_date": "20050722", "listing_expiration_date": "20261231"}