0054-0292 : Eszopiclone 3 mg Oral Tablet


NDC0054-0292
Labeler: Roxane Laboratories, Inc.
Product Type: Human Prescription Drug
Drug Name:  Eszopiclone
Dosage Form: Oral Tablet
Application #: ANDA091153
Rev. Date: 
CSA Schedule: CIV (US) [1]


[1] Schedule IV Controlled Substance: Low potential for abuse relative to substances in Schedule III. Examples include Alprazolam (Xanax), Diazepam (Valium), Carisoprodol (Soma), Clonazepam (Klonopin), Lorazepam (Ativan), Clorazepate (Tranxene), Midazolam (Versed), Temazepam (Restoril), and Triazolam (Halcion).. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: 54;396
Shapes:  Round
Colors:  White
Size (mm): 9
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 0054-0292-25: 100 TABLET IN 1 BOTTLE (0054‑0292‑25)

Active Ingredients:

  • Eszopiclone

Dosage Strength:

  • 3 mg

Inactive Ingredients:

  • Cellulose, Microcrystalline
  • Anhydrous Lactose
  • Croscarmellose Sodium
  • Silicon Dioxide
  • Magnesium Stearate
  • Titanium Dioxide
  • Polydextrose
  • Hypromelloses
  • Triacetin
  • Polyethylene Glycol 8000

Related Products:

Based on records with the same trade name.
  • 0054-0290 Eszopiclone 1 mg Oral Tablet by Roxane Laboratories, Inc.
  • 0054-0291 Eszopiclone 2 mg Oral Tablet by Roxane Laboratories, Inc.
  • 0093-5537 Eszopiclone 1 mg Oral Tablet, Film Coated by Teva Pharmaceuticals USA Inc
  • 0093-5538 Eszopiclone 2 mg Oral Tablet, Film Coated by Teva Pharmaceuticals USA Inc
  • 0093-5539 Eszopiclone 3 mg Oral Tablet, Film Coated by Teva Pharmaceuticals USA Inc
  • 0378-5270 Eszopiclone 1 mg Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
  • 0378-5271 Eszopiclone 2 mg Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
  • 0378-5272 Eszopiclone 3 mg Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
  • 33342-299 Eszopiclone 1 mg Oral Tablet, Film Coated by Macleods Pharmaceuticals Limited
  • 33342-300 Eszopiclone 2 mg Oral Tablet, Film Coated by Macleods Pharmaceuticals Limited
  • 33342-301 Eszopiclone 3 mg Oral Tablet, Film Coated by Macleods Pharmaceuticals Limited
  • 42043-320 Eszopiclone 1 mg Oral Tablet, Film Coated by Orchidpharma Inc
  • 42043-321 Eszopiclone 2 mg Oral Tablet, Film Coated by Orchidpharma Inc
  • 42043-322 Eszopiclone 3 mg Oral Tablet, Film Coated by Orchidpharma Inc
  • 42291-271 Eszopiclone 1 mg Oral Tablet, Film Coated by Avkare, Inc.
  • 42291-272 Eszopiclone 2 mg Oral Tablet, Film Coated by Avkare, Inc.
  • 42291-273 Eszopiclone 3 mg Oral Tablet, Film Coated by Avkare, Inc.
  • 43063-795 Eszopiclone 3 mg Oral Tablet, Film Coated by Pd-rx Pharmaceuticals, Inc.
  • 43353-097 Eszopiclone 3 mg Oral Tablet, Film Coated by Aphena Pharma Solutions - Tennessee, LLC
  • 43353-101 Eszopiclone 2 mg Oral Tablet, Film Coated by Aphena Pharma Solutions - Tennessee, LLC
  • More related products ...

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 0054-0292 QR Code

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