50436-0301 : Eszopiclone 3 mg Oral Tablet, Film Coated


NDC: 50436-0301
Labeler: Unit Dose Services
Product Type: Human Prescription Drug
Drug Name:  Eszopiclone
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA202929
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: L36
Shapes:  Round
Colors:  Blue
Size (mm): 6
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:

  • 50436-0301-1: 30 TABLET, FILM COATED IN 1 BOTTLE (50436‑0301‑1)

Active Ingredients:

  • Eszopiclone

Dosage Strength:

  • 3 mg

Inactive Ingredients:

  • Dibasic Calcium Phosphate Dihydrate
  • Silicon Dioxide
  • Croscarmellose Sodium
  • Hypromellose, Unspecified
  • Lactose Monohydrate
  • Magnesium Stearate
  • Microcrystalline Cellulose
  • Polyethylene Glycol, Unspecified
  • Titanium Dioxide
  • Triacetin
  • Fd&c Blue No. 2

Related Products:

Based on records with the same trade name.
  • 50436-0299 Eszopiclone 1 mg Oral Tablet, Film Coated by Unit Dose Services
  • 50436-0300 Eszopiclone 2 mg Oral Tablet, Film Coated by Unit Dose Services
  • 50436-0320 Eszopiclone 1 mg Oral Tablet, Film Coated by Unit Dose Services
  • 50436-0322 Eszopiclone 3 mg Oral Tablet, Film Coated by Unit Dose Services
  • 50436-0619 Eszopiclone 2 mg Oral Tablet, Coated by Unit Dose Services
  • 50436-3383 Eszopiclone 2 mg Oral Tablet, Film Coated by Unit Dose Services
  • 50436-3384 Eszopiclone 3 mg Oropharyngeal Tablet, Film Coated by Unit Dose Services
  • 50436-5537 Eszopiclone 1 mg Oral Tablet, Film Coated by Unit Dose Services
  • 50436-5538 Eszopiclone 2 mg Oral Tablet, Film Coated by Unit Dose Services
  • 50436-5539 Eszopiclone 3 mg Oral Tablet, Film Coated by Unit Dose Services
  • 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
  • 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.
  • 31722-855 Eszopiclone 1 mg Oral Tablet, Film Coated by Camber Pharmaceuticals, Inc.
  • More related products ...

NDC QR Code

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NDC 50436-0301 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.