0378-3750 : Phenytek 300 mg Extended Release Capsule


NDC0378-3750
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Phenytek
Dosage Form: Oral Capsule, Extended Release
Application #: ANDA040298
Rev. Date: 


Appearance:


Markings: BERTEK;750
Shapes:  Capsule
Colors:  Blue / Blue
Size (mm): 18
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.

BERTEK 750: (0378-3750) Phenytek 300 mg Extended Release Capsule 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:

  • 0378-3750-01: 100 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (0378‑3750‑01)
  • 0378-3750-93: 30 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (0378‑3750‑93)

Active Ingredients:

  • Phenytoin Sodium

Dosage Strength:

  • 300 mg

Inactive Ingredients:

  • Ferrosoferric Oxide
  • Silicon Dioxide
  • D&c Yellow No. 10
  • Fd&c Blue No. 1
  • Fd&c Blue No. 2
  • Fd&c Red No. 40
  • Gelatin
  • Magnesium Oxide
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Povidones
  • Propylene Glycol
  • Sodium Lauryl Sulfate
  • Titanium Dioxide
  • Hydroxyethyl Cellulose (2000 Mpa.s At 1%)
  • Shellac

Pharmaceutical Classes:

  • Anti-epileptic Agent [EPC]
  • Decreased Central Nervous System Disorganized Electrical Activity [PE]
  • Cytochrome P450 1A2 Inducers [MoA]
  • Cytochrome P450 2B6 Inducers [MoA]
  • Cytochrome P450 2C8 Inducers [MoA]
  • Cytochrome P450 2C19 Inducers [MoA]
  • Cytochrome P450 2D6 Inducers [MoA]
  • Cytochrome P450 3A Inducers [MoA]
  • Cytochrome P450 2C9 Inducers [MoA]

Related Products:

Based on records with the same trade name.
  • 0378-2670 Phenytek 200 mg Extended Release Capsule by Mylan Pharmaceuticals Inc.
  • 58118-3750 Phenytek 300 mg Oral Capsule, Extended Release by Clinical Solutions Wholesale

NDC QR Code

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

NDC 0378-3750 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.