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  4. NDC Product Code: 67544-517 Phenytoin Sodium

NDC 67544-517 Phenytoin Sodium

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 67544-517?
  5. Phenytoin Sodium Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
67544-517
Proprietary Name:
Phenytoin Sodium
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Aphena Pharma Solutions - Tennessee, Llc
Labeler Code:
67544
Product Label ID:
404bb4d0-dade-4fb7-a85d-d5233d49fd98
Start Marketing Date: [9]
01-05-1999
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
PURPLE (C48327 - LIGHT LAVENDER OPAQUE)
WHITE (C48325 - WHITE OPAQUE)
Shape:
CAPSULE (C48336)
Size(s):
12 MM
Imprint(s):
MYLAN;1560
Score:
1

Product Packages

NDC Code 67544-517-92

Package Description: 270 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

NDC Code 67544-517-94

Package Description: 360 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

Product Details

What is NDC 67544-517?

The NDC code 67544-517 is assigned by the FDA to the product Phenytoin Sodium which is product labeled by Aphena Pharma Solutions - Tennessee, Llc. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 67544-517-92 270 capsule, extended release in 1 bottle, plastic , 67544-517-94 360 capsule, extended release in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Phenytoin Sodium?

Extended phenytoin sodium capsules, USP are indicated for the control of generalized tonic-clonic (grand mal) and 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).

Which are Phenytoin Sodium UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Phenytoin Sodium Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Phenytoin Sodium?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 855671 - phenytoin sodium 100 MG Extended Release Oral Capsule
  • RxCUI: 855671 - DPH sodium 100 MG Extended Release Oral Capsule

* Please review the disclaimer below.

Patient Education

Phenytoin


Phenytoin is used to control certain type of seizures, and to treat and prevent seizures that may begin during or after surgery to the brain or nervous system. Phenytoin is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".