NDC 68788-9991

ESZOPICLONE

Eszopiclone

ESZOPICLONE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals, Inc.. The primary component is Eszopiclone.

• Product ID: 68788-9991_909db0ea-a14f-47fb-9f0a-1277d62ccb58
• NDC: 68788-9991
• Product Type: Human Prescription Drug
• Proprietary Name: ESZOPICLONE
• Generic Name: Eszopiclone
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2014-04-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091103
• Labeler Name: Preferred Pharmaceuticals, Inc.
• Substance Name: ESZOPICLONE
• Active Ingredient Strength: 2 mg/1
• DEA Schedule: CIV
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 68788-9991-9

90 TABLET, FILM COATED in 1 BOTTLE (68788-9991-9)

• Marketing Start Date: 2014-04-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68788-9991-6 [68788999106]

ESZOPICLONE TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA091103
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-04-15
• Marketing End Date: 2019-09-10

NDC 68788-9991-3 [68788999103]

ESZOPICLONE TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA091103
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-04-15
• Marketing End Date: 2019-09-10

NDC 68788-9991-1 [68788999101]

ESZOPICLONE TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA091103
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-04-15
• Marketing End Date: 2019-09-10

NDC 68788-9991-2 [68788999102]

ESZOPICLONE TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA091103
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-04-15
• Marketing End Date: 2019-09-10

NDC 68788-9991-9 [68788999109]

ESZOPICLONE TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA091103
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-04-15
• Marketing End Date: 2019-09-10

Drug Details

Active Ingredients

Ingredient	Strength
ESZOPICLONE	2 mg/1

OpenFDA Data

• SPL SET ID: ebe375bb-d43d-4e9d-b7ff-c71ebbebf6d2
• Manufacturer:
  • Preferred Pharmaceuticals, Inc.
• UNII:
  • UZX80K71OE
• RxNorm Concept Unique ID - RxCUI:
  • 485440
  • 485442

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

NDC	Brand Name	Generic Name
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
68071-2153	eszopiclone	eszopiclone
68071-3376	Eszopiclone	Eszopiclone
68180-322	Eszopiclone	Eszopiclone
68180-324	Eszopiclone	Eszopiclone
68180-323	Eszopiclone	Eszopiclone
68462-382	Eszopiclone	Eszopiclone
68462-384	Eszopiclone	Eszopiclone
68462-383	Eszopiclone	Eszopiclone
68788-7029	Eszopiclone	Eszopiclone
68788-7169	Eszopiclone	Eszopiclone
68788-8923	Eszopiclone	Eszopiclone
68788-9361	eszopiclone	eszopiclone
68788-9238	eszopiclone	eszopiclone
68788-6953	Eszopiclone	Eszopiclone
68788-8953	ESZOPICLONE	ESZOPICLONE
68788-9296	ESZOPICLONE	ESZOPICLONE
68788-9315	ESZOPICLONE	ESZOPICLONE
68788-9824	ESZOPICLONE	ESZOPICLONE
68788-9318	Eszopiclone	Eszopiclone
68788-9991	ESZOPICLONE	ESZOPICLONE
70518-0815	Eszopiclone	Eszopiclone
70518-0816	Eszopiclone	Eszopiclone
70518-1310	ESZOPICLONE	ESZOPICLONE
70518-0888	Eszopiclone	Eszopiclone
71205-236	ESZOPICLONE	ESZOPICLONE
71335-0512	Eszopiclone	Eszopiclone
71335-0089	Eszopiclone	Eszopiclone
71335-0148	ESZOPICLONE	ESZOPICLONE
71335-0116	Eszopiclone	Eszopiclone
71335-0784	eszopiclone	eszopiclone
71335-0005	ESZOPICLONE	ESZOPICLONE
71335-0598	Eszopiclone	Eszopiclone
42043-320	ESZOPICLONE	ESZOPICLONE
42043-321	ESZOPICLONE	ESZOPICLONE
42043-322	ESZOPICLONE	ESZOPICLONE
43063-795	Eszopiclone	Eszopiclone
43353-101	Eszopiclone	Eszopiclone
43353-185	Eszopiclone	Eszopiclone