NDC 70710-1344

Ramelteon

Ramelteon

Ramelteon is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Ramelteon.

• Product ID: 70710-1344_61413940-2f21-450e-93ef-7689f114932d
• NDC: 70710-1344
• Product Type: Human Prescription Drug
• Proprietary Name: Ramelteon
• Generic Name: Ramelteon
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2019-07-23
• Marketing Category: ANDA / ANDA
• Application Number: ANDA211567
• Labeler Name: Zydus Pharmaceuticals (USA) 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: 2022-12-31

Packaging

NDC 70710-1344-1

100 TABLET in 1 BOTTLE (70710-1344-1)

• Marketing Start Date: 2019-07-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70710-1344-3 [70710134403]

Ramelteon TABLET

• Marketing Category: ANDA
• Application Number: ANDA211567
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-07-23

NDC 70710-1344-1 [70710134401]

Ramelteon TABLET

• Marketing Category: ANDA
• Application Number: ANDA211567
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-07-23

NDC 70710-1344-5 [70710134405]

Ramelteon TABLET

• Marketing Category: ANDA
• Application Number: ANDA211567
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-23

Drug Details

Active Ingredients

Ingredient	Strength
RAMELTEON	8 mg/1

OpenFDA Data

• SPL SET ID: 5db0e3ff-fefb-4c54-b9f9-b555e482e147
• Manufacturer:
  • Zydus Pharmaceuticals (USA) Inc.
• UNII:
  • 901AS54I69
• RxNorm Concept Unique ID - RxCUI:
  • 577348
• UPC Code:
  • 0370710134433

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
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
21695-183	Rozerem	ramelteon
63629-3389	Rozerem	ramelteon
64764-805	Rozerem	ramelteon
68151-4881	Rozerem	ramelteon