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  5. NDC Package Code: 62756-299-13 Phenytoin Sodium

NDC Package 62756-299-13 Phenytoin Sodium

Capsule, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
62756-299-13
Package Description:
500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code:
62756-299
Proprietary Name:
Phenytoin Sodium
Non-Proprietary Name:
Phenytoin Sodium
Substance Name:
Phenytoin Sodium
Usage Information:
Extended phenytoin sodium capsules, USP are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY).
11-Digit NDC Billing Format:
62756029913
NDC to RxNorm Crosswalk:
  • RxCUI: 855861 - phenytoin sodium 200 MG Extended Release Oral Capsule
  • RxCUI: 855861 - DPH sodium 200 MG Extended Release Oral Capsule
  • RxCUI: 855873 - phenytoin sodium 300 MG Extended Release Oral Capsule
  • RxCUI: 855873 - DPH sodium 300 MG Extended Release Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sun Pharmaceutical Industries, Inc.
    Dosage Form:
    Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • PHENYTOIN SODIUM 200 mg/1
    • Pharmacologic Class(es):
  • Anti-epileptic Agent - [EPC] (Established Pharmacologic Class)
  • Cytochrome P450 1A2 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2B6 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C19 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C8 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C9 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2D6 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A Inducers - [MoA] (Mechanism of Action)
  • Decreased Central Nervous System Disorganized Electrical Activity - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    ANDA040731
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-30-2008
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    62756-299-08100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
    62756-299-8330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
    62756-299-88100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 62756-299-13?

    The NDC Packaged Code 62756-299-13 is assigned to a package of 500 capsule, extended release in 1 bottle of Phenytoin Sodium, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. The product's dosage form is capsule, extended release and is administered via oral form.

    Is NDC 62756-299 included in the NDC Directory?

    Yes, Phenytoin Sodium with product code 62756-299 is active and included in the NDC Directory. The product was first marketed by Sun Pharmaceutical Industries, Inc. on June 30, 2008 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 62756-299-13?

    The 11-digit format is 62756029913. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-262756-299-135-4-262756-0299-13