61919-991 : Eszopiclone 1 mg Oral Tablet, Film Coated


NDC: 61919-991
Labeler: Directrx
Product Type: Human Prescription Drug
Drug Name:  Eszopiclone
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA091166
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: 382;G
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:

  • 61919-991-30: 30 TABLET, FILM COATED IN 1 BOTTLE (61919‑991‑30)
  • 61919-991-60: 60 TABLET, FILM COATED IN 1 BOTTLE (61919‑991‑60)
  • 61919-991-90: 90 TABLET, FILM COATED IN 1 BOTTLE (61919‑991‑90)

Active Ingredients:

  • Eszopiclone

Dosage Strength:

  • 1 mg

Inactive Ingredients:

  • Anhydrous Lactose
  • Silicon Dioxide
  • Croscarmellose Sodium
  • Calcium Phosphate, Dibasic, Anhydrous
  • Hypromelloses
  • Lactose Monohydrate
  • Magnesium Stearate
  • Polyethylene Glycols
  • Titanium Dioxide
  • Triacetin
  • Fd&c Blue No. 2
  • Cellulose, Microcrystalline

Related Products:

Based on records with the same trade name.
  • 61919-323 Eszopiclone 1 mg Oral Tablet, Film Coated by Directrx
  • 61919-033 Eszopiclone 2 mg Oral Tablet, Film Coated by Direct Rx
  • 61919-119 Eszopiclone 1 mg Oral Tablet, Film Coated by Direct Rx
  • 61919-395 Eszopiclone 3 mg Oral Tablet, Film Coated by Direct Rx
  • 61919-462 Eszopiclone 3 mg Oral Tablet by Direct Rx
  • 61919-500 Eszopiclone 3 mg Oral Tablet, Film Coated by Direct Rx
  • 61919-502 Eszopiclone 1 mg Oral Tablet, Film Coated by Direct Rx
  • 61919-514 Eszopiclone 3 mg Oral Tablet, Film Coated by Direct Rx
  • 61919-587 Eszopiclone 2 mg Oral Tablet, Film Coated by Direct Rx
  • 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.
  • 31722-856 Eszopiclone 2 mg Oral Tablet, Film Coated by Camber Pharmaceuticals, Inc.
  • More related products ...

NDC QR Code

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

NDC 61919-991 QR Code

< Prev: 61919-990Next: 61919-992 >

Related Discussions:

Eszopiclone (lunesta) Orange Tablets, no imprints
Small orange/peach round, uncoated pill from INDIA. No markings. They are supposed to be eszopisclone (generic lunesta).... 2 replies
Eszopiclone for old man (87 years old)
My father (87 years old) was consuming clonazepam for long time for sleep, around 1 year, and I think now he is resistan...
Side effects of eszopiclone manufactured by roxane
Are the side effects more common with the manufacturer Roxane versus Teva for the drug eszopiclone? ## No, it is still t... 1 reply




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.