NDC 16590-815 Phenytoin ER

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
16590-815
Proprietary Name:
Phenytoin ER
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Labeler Code:
16590
Start Marketing Date: [9]
11-20-2009
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
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

Code Structure Chart

Product Details

What is NDC 16590-815?

The NDC code 16590-815 is assigned by the FDA to the product Phenytoin ER which is product labeled by Stat Rx Usa Llc. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 16590-815-30 30 capsule in 1 bottle, plastic , 16590-815-60 60 capsule in 1 bottle, plastic , 16590-815-82 180 capsule in 1 bottle, plastic , 16590-815-90 90 capsule 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 ER?

Phenytoin is used to prevent and control seizures (also called an anticonvulsant or antiepileptic drug). It works by reducing the spread of seizure activity in the brain.

Which are Phenytoin ER UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Phenytoin ER?

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.

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".