10135-603 : Extended Phenytoin Sodium 100 mg Oral Capsule, Extended Release


NDC: 10135-603
Labeler: Marlex Pharmaceuticals Inc
Product Type: Human Prescription Drug
Drug Name:  Extended Phenytoin Sodium
Dosage Form: Oral Capsule, Extended Release
Application #: ANDA040765
Rev. Date: 


Appearance:


Markings: IP;212
Shapes:  Capsule
Colors:  White
Size (mm): 16
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.

IP 212: (68084-376) Extended Phenytoin Sodium 100 mg Oral Capsule, Extended Release by Marlex 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:

  • 10135-603-01: 100 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (10135‑603‑01)
  • 10135-603-10: 1000 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (10135‑603‑10)

Active Ingredients:

  • Phenytoin Sodium

Dosage Strength:

  • 100 mg

Inactive Ingredients:

  • D&c Red No. 28
  • D&c Red No. 33
  • Fd&c Blue No. 1
  • Gelatin
  • Hydroxypropyl Cellulose (Type H)
  • Mannitol
  • Magnesium Stearate
  • Talc
  • Titanium Dioxide

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.
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  • 42291-772 Extended Phenytoin Sodium 100 mg Oral Capsule by Avkare
  • 43063-492 Extended Phenytoin Sodium 100 mg/1 Oral Capsule by Pd-rx Pharmaceuticals, Inc.
  • 49349-471 Dph Sodium 100 mg Oral Capsule by Remedyrepack Inc.
  • 50090-2089 Extended Phenytoin Sodium 100 mg Oral Capsule by A-s Medication Solutions
  • 50090-3142 Extended Phenytoin Sodium 100 mg Oral Capsule by A-s Medication Solutions
  • 50090-3165 Extended Phenytoin Sodium 100 mg Oral Capsule by A-s Medication Solutions
  • 52125-176 Dph Sodium 100 mg Extended Release Capsule by Remedyrepack Inc.
  • 52125-300 Dph Sodium 100 mg Extended Release Capsule by Remedyrepack Inc.
  • 53808-1040 Extended Phenytoin Sodium 100 mg Oral Capsule by State of Florida Doh Central Pharmacy
  • 54569-5151 Extended Phenytoin Sodium 100 mg Oral Capsule by A-s Medication Solutions
  • 55154-7979 Extended Phenytoin Sodium 100 mg Oral Capsule by Cardinal Health
  • 55289-906 Dph Sodium 100 mg Extended Release Capsule by Pd-rx Pharmaceuticals, Inc.
  • 55648-720 Dph Sodium 100 mg Extended Release Capsule by Wockhardt Limited
  • 61786-012 Extended Phenytoin Sodium 100 mg Oral Capsule by Remedyrepack Inc.
  • 61786-637 Extended Phenytoin Sodium 100 mg Oral Capsule by Remedyrepack Inc.
  • 64679-720 Dph Sodium 100 mg Extended Release Capsule by Wockhardt USA LLC.
  • 64725-0720 Extended Phenytoin Sodium 100 mg Oral Capsule by Tya Pharmaceuticals
  • 65162-212 Extended Phenytoin Sodium (Phenytoin Sodium 100 mg) by Amneal Pharmaceuticals, LLC
  • 65862-692 Extended Phenytoin Sodium 100 mg Oral Capsule by Aurobindo Pharma Limited
  • More related products ...

NDC QR Code

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NDC 10135-603 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.