NDC 64764-805

Rozerem

Ramelteon

Rozerem is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Ramelteon.

• Product ID: 64764-805_2dd3b589-791d-4151-8d80-357f6144d565
• NDC: 64764-805
• Product Type: Human Prescription Drug
• Proprietary Name: Rozerem
• Generic Name: Ramelteon
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2005-07-22
• Marketing Category: NDA / NDA
• Application Number: NDA021782
• Labeler Name: Takeda Pharmaceuticals America, Inc.
• Substance Name: RAMELTEON
• Active Ingredient Strength: 8 mg/1
• Pharm Classes: Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2024-12-31

Packaging

NDC 64764-805-10

100 TABLET, FILM COATED in 1 BOTTLE (64764-805-10)

• Marketing Start Date: 2005-07-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64764-805-10 [64764080510]

Rozerem TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021782
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2005-07-22

NDC 64764-805-50 [64764080550]

Rozerem TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021782
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2005-07-22
• Marketing End Date: 2010-11-22

NDC 64764-805-22 [64764080522]

Rozerem TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021782
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2005-07-22

NDC 64764-805-30 [64764080530]

Rozerem TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021782
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2005-07-22

Drug Details

Active Ingredients

Ingredient	Strength
RAMELTEON	8 mg/1

OpenFDA Data

• SPL SET ID: 9de82310-70e8-47b9-b1fc-6c6848b99455
• Manufacturer:
  • Takeda Pharmaceuticals America, Inc.
• UNII:
  • 901AS54I69
• RxNorm Concept Unique ID - RxCUI:
  • 603162
  • 577348
• UPC Code:
  • 0364764805302

Pharmacological Class

• Melatonin Receptor Agonist [EPC]
• Melatonin Receptor Agonists [MoA]
• Melatonin Receptor Agonist [EPC]
• Melatonin Receptor Agonists [MoA]

Medicade Reported Pricing

64764080530 ROZEREM 8 MG TABLET

Pricing Unit: EA | Drug Type:

64764080510 ROZEREM 8 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Rozerem" or generic name "Ramelteon"

NDC	Brand Name	Generic Name
21695-183	Rozerem	ramelteon
63629-3389	Rozerem	ramelteon
64764-805	Rozerem	ramelteon
68151-4881	Rozerem	ramelteon
0591-2191	Ramelteon	Ramelteon
0832-1250	Ramelteon	Ramelteon
42291-776	Ramelteon	Ramelteon
43598-741	Ramelteon	Ramelteon
50268-708	Ramelteon	Ramelteon
50436-3980	Ramelteon	Ramelteon
51407-375	Ramelteon	Ramelteon
52817-235	Ramelteon	Ramelteon
55700-874	Ramelteon	Ramelteon
63629-8264	Ramelteon	Ramelteon
63629-8531	Ramelteon	Ramelteon
70010-028	Ramelteon	Ramelteon
70710-1344	Ramelteon	Ramelteon
70771-1495	Ramelteon	Ramelteon
71205-918	Ramelteon	Ramelteon
71335-1853	Ramelteon	Ramelteon
71335-2186	Ramelteon	Ramelteon
72189-153	RAMELTEON	RAMELTEON
72189-369	Ramelteon	Ramelteon
72319-005	Ramelteon	Ramelteon
80425-0203	Ramelteon	Ramelteon