0378-5575 : Modafinil 200 mg Oral Tablet


NDC: 0378-5575
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Modafinil
Dosage Form: Oral Tablet
Application #: ANDA076594
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;575
Shapes:  Oval
Colors:  White
Size (mm): 15
Segments: * 2

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

M 575: (0378-5575) Modafinil 200 mg Oral Tablet by Mylan Pharmaceuticals Inc.
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 0378-5575-01: 100 TABLET IN 1 BOTTLE, PLASTIC (0378‑5575‑01)
  • 0378-5575-05: 500 TABLET IN 1 BOTTLE, PLASTIC (0378‑5575‑05)
  • 0378-5575-77: 90 TABLET IN 1 BOTTLE, PLASTIC (0378‑5575‑77)
  • 0378-5575-93: 30 TABLET IN 1 BOTTLE, PLASTIC (0378‑5575‑93)

Active Ingredients:

  • Modafinil

Dosage Strength:

  • 200 mg

Inactive Ingredients:

  • Croscarmellose Sodium
  • Calcium Phosphate, Dibasic, Anhydrous
  • Lactose Monohydrate
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Povidones

Pharmaceutical Classes:

  • Central Nervous System Stimulation [PE]
  • Increased Sympathetic Activity [PE]
  • Sympathomimetic-like Agent [EPC]

Related Products:

Based on records with the same trade name.
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  • 0143-9969 Modafinil 200 mg Oral Tablet by West-ward Pharmaceuticals Corp
  • 0591-3499 Modafinil 100 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-3500 Modafinil 200 mg Oral Tablet by Watson Laboratories, Inc.
  • 0603-4661 Modafinil 100 mg Oral Tablet by Qualitest Pharmaceuticals
  • 0603-4662 Modafinil 200 mg Oral Tablet by Qualitest Pharmaceuticals
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  • 0904-6424 Modafinil 200 mg Oral Tablet by Major Pharmaceuticals
  • 0904-6791 Modafinil 100 mg Oral Tablet by Major Pharmaceuticals
  • 0904-6792 Modafinil 200 mg Oral Tablet by Major Pharmaceuticals
  • 23155-604 Modafinil 100 mg Oral Tablet by Heritage Pharmaceuticals Inc.
  • 23155-605 Modafinil 200 mg Oral Tablet by Heritage Pharmaceuticals Inc.
  • 23155-862 Modafinil 200 mg Oral Tablet by Heritage Pharmaceuticals Inc. D/B/A Avet Pharmaceuticals Inc.
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  • 42043-161 Modafinil 200 mg Oral Tablet by Orchidpharma Inc
  • 42291-599 Modafinil 100 mg/1 Oral Tablet by Avkare, Inc.
  • 42291-600 Modafinil 200 mg/1 Oral Tablet by Avkare, Inc.
  • 42549-678 Modafinil 200 mg Oral Tablet by Stat Rx USA LLC
  • 43353-831 Modafinil 200 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, LLC
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NDC QR Code

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NDC 0378-5575 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.