NDC 21695-167 Phenytoin Sodium

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:
21695-167
Proprietary Name:
Phenytoin Sodium
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Rebel Distributors Corp
Labeler Code:
21695
Start Marketing Date: [9]
09-05-2006
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
ORANGE (C48331 - OPAQUE)
Shape:
CAPSULE (C48336)
Size(s):
16 MM
Imprint(s):
TARO;PHN;100
Score:
1

Product Packages

NDC Code 21695-167-30

Package Description: 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

NDC Code 21695-167-72

Package Description: 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

NDC Code 21695-167-90

Package Description: 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

Product Details

What is NDC 21695-167?

The NDC code 21695-167 is assigned by the FDA to the product Phenytoin Sodium which is product labeled by Rebel Distributors Corp. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 21695-167-30 30 capsule, extended release in 1 bottle , 21695-167-72 120 capsule, extended release in 1 bottle , 21695-167-90 90 capsule, extended release in 1 bottle . 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, 100 mg 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).

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.

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".