NDC 55289-014

Lunesta

Eszopiclone

Lunesta is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Eszopiclone.

• Product ID: 55289-014_84b58da5-4114-f3c1-e053-2991aa0aeb82
• NDC: 55289-014
• Product Type: Human Prescription Drug
• Proprietary Name: Lunesta
• Generic Name: Eszopiclone
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2005-04-04
• Marketing Category: NDA / NDA
• Application Number: NDA021476
• Labeler Name: PD-Rx Pharmaceuticals, Inc.
• Substance Name: ESZOPICLONE
• Active Ingredient Strength: 3 mg/1
• DEA Schedule: CIV
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 55289-014-30

30 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-014-30)

• Marketing Start Date: 2011-07-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55289-014-30 [55289001430]

Lunesta TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA021476
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-07-27

Drug Details

Active Ingredients

Ingredient	Strength
ESZOPICLONE	3 mg/1

OpenFDA Data

• SPL SET ID: 8b2dc950-9dc2-4bd2-bfc2-2fb859ef81c4
• Manufacturer:
  • PD-Rx Pharmaceuticals, Inc.
• UNII:
  • UZX80K71OE
• RxNorm Concept Unique ID - RxCUI:
  • 485465
  • 540411

NDC Crossover Matching brand name "Lunesta" or generic name "Eszopiclone"

NDC	Brand Name	Generic Name
21695-225	Lunesta	eszopiclone
21695-226	Lunesta	eszopiclone
68258-7048	Lunesta	Lunesta
68258-7049	Lunesta	Lunesta
50436-0193	Lunesta	Lunesta
52959-919	Lunesta	Lunesta
52959-852	Lunesta	Lunesta
55289-014	Lunesta	Lunesta
63402-190	Lunesta	Lunesta
63629-3142	Lunesta	Lunesta
63402-191	Lunesta	Lunesta
63402-193	Lunesta	Lunesta
80425-0115	Lunesta	Lunesta
80425-0064	Lunesta	Lunesta
80425-0062	Lunesta	Lunesta
80425-0098	Lunesta	Lunesta
80425-0066	Lunesta	Lunesta
80425-0067	Lunesta	Lunesta
80425-0065	Lunesta	Lunesta
80425-0063	Lunesta	Lunesta
0054-0290	eszopiclone	eszopiclone
0054-0291	eszopiclone	eszopiclone
0054-0292	eszopiclone	eszopiclone
0093-5537	Eszopiclone	Eszopiclone
0093-5538	Eszopiclone	Eszopiclone
0093-5539	Eszopiclone	Eszopiclone
0378-5270	Eszopiclone	eszopiclone
0378-5271	Eszopiclone	eszopiclone
0378-5272	Eszopiclone	eszopiclone
33342-299	Eszopiclone	Eszopiclone
33342-300	Eszopiclone	Eszopiclone
33342-301	Eszopiclone	Eszopiclone