0378-5272 : Eszopiclone 3 mg Oral Tablet, Film Coated


NDC: 0378-5272
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Eszopiclone
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA091151
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: M;EZ;3
Shapes:  Round
Colors:  White
Size (mm): 8
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:

  • 0378-5272-01: 100 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑5272‑01)
  • 0378-5272-10: 1000 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑5272‑10)

Active Ingredients:

  • Eszopiclone

Dosage Strength:

  • 3 mg

Inactive Ingredients:

  • Ferrosoferric Oxide
  • Silicon Dioxide
  • Croscarmellose Sodium
  • Hypromelloses
  • Lactose Monohydrate
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polyethylene Glycols
  • Ferric Oxide Red
  • Titanium Dioxide
  • Ferric Oxide Yellow

Related Products:

Based on records with the same trade name.
  • 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.
  • 0054-0290 Eszopiclone 1 mg Oral Tablet by Roxane Laboratories, Inc.
  • 0054-0291 Eszopiclone 2 mg Oral Tablet by Roxane Laboratories, Inc.
  • 0054-0292 Eszopiclone 3 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
  • 31722-855 Eszopiclone 1 mg Oral Tablet, Film Coated by Camber Pharmaceuticals, Inc.
  • 31722-856 Eszopiclone 2 mg Oral Tablet, Film Coated by Camber Pharmaceuticals, Inc.
  • 31722-857 Eszopiclone 3 mg Oral Tablet, Film Coated by Camber 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.
  • More related products ...

NDC QR Code

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NDC 0378-5272 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.