65862-805 : Armodafinil 50 mg Oral Tablet


NDC: 65862-805
Labeler: Aurobindo Pharma Limited
Product Type: Human Prescription Drug
Drug Name:  Armodafinil
Dosage Form: Oral Tablet
Application #: ANDA206069
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: K;58
Shapes:  Round
Colors:  White
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:

  • 65862-805-05: 500 TABLET IN 1 BOTTLE (65862‑805‑05)
  • 65862-805-30: 30 TABLET IN 1 BOTTLE (65862‑805‑30)
  • 65862-805-60: 60 TABLET IN 1 BOTTLE (65862‑805‑60)

Active Ingredients:

  • Armodafinil

Dosage Strength:

  • 50 mg

Inactive Ingredients:

  • Croscarmellose Sodium
  • Lactose Monohydrate
  • Magnesium Stearate
  • Povidone K30 /

Related Products:

Based on records with the same trade name.
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  • 65862-807 Armodafinil 250 mg Oral Tablet by Aurobindo Pharma Limited
  • 65862-998 Armodafinil 200 mg Oral Tablet by Aurobindo Pharma Limited
  • 59651-047 Armodafinil 200 mg Oral Tablet by Aurobindo Pharma Limited
  • 0093-3090 Armodafinil 50 mg Oral Tablet by Teva Pharmaceuticals USA, Inc.
  • 0093-3092 Armodafinil 150 mg Oral Tablet by Teva Pharmaceuticals USA, Inc.
  • 0093-3093 Armodafinil 200 mg Oral Tablet by Teva Pharmaceuticals USA, Inc.
  • 0093-3094 Armodafinil 250 mg Oral Tablet by Teva Pharmaceuticals USA, Inc.
  • 0378-3431 Armodafinil 50 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-3432 Armodafinil 150 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-3433 Armodafinil 250 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0591-3703 Armodafinil 100 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-3704 Armodafinil 200 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-3856 Armodafinil 200 mg Oral Tablet by Actavis Pharma, Inc.
  • 0781-8029 Armodafinil 50 mg Oral Tablet by Sandoz Inc.
  • 0781-8037 Armodafinil 150 mg Oral Tablet by Sandoz Inc.
  • 0781-8045 Armodafinil 200 mg Oral Tablet by Sandoz Inc.
  • 0781-8053 Armodafinil 250 mg Oral Tablet by Sandoz Inc.
  • 51991-322 Armodafinil 50 mg Oral Tablet by Breckenridge Pharmaceutical, Inc.
  • 51991-323 Armodafinil 150 mg Oral Tablet by Breckenridge Pharmaceutical, Inc.
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NDC 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.