NDC 70518-2293 Phenytoin Sodium
Capsule, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
Code Structure Chart
Product Details
What is NDC 70518-2293?
What are the uses for Phenytoin Sodium?
What are Phenytoin Sodium Active Ingredients?
- PHENYTOIN SODIUM 100 mg/1 - An anticonvulsant that is used to treat a wide variety of seizures. It is also an anti-arrhythmic and a muscle relaxant. The mechanism of therapeutic action is not clear, although several cellular actions have been described including effects on ion channels, active transport, and general membrane stabilization. The mechanism of its muscle relaxant effect appears to involve a reduction in the sensitivity of muscle spindles to stretch. Phenytoin has been proposed for several other therapeutic uses, but its use has been limited by its many adverse effects and interactions with other drugs.
Which are Phenytoin Sodium UNII Codes?
The UNII codes for the active ingredients in this product are:
- PHENYTOIN SODIUM (UNII: 4182431BJH)
- PHENYTOIN (UNII: 6158TKW0C5) (Active Moiety)
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:
- SUCROSE (UNII: C151H8M554)
- HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
- LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- TALC (UNII: 7SEV7J4R1U)
- BENZYL ALCOHOL (UNII: LKG8494WBH)
- BUTYLPARABEN (UNII: 3QPI1U3FV8)
- D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
- EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
- FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
- GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
- METHYLPARABEN (UNII: A2I8C7HI9T)
- PROPYLPARABEN (UNII: Z8IX2SC1OH)
- SODIUM LAURYL SULFATE (UNII: 368GB5141J)
- SODIUM PROPIONATE HYDRATE (UNII: DK6Y9P42IN)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
What is the NDC to RxNorm Crosswalk for Phenytoin Sodium?
- RxCUI: 855671 - phenytoin sodium 100 MG Extended Release Oral Capsule
- RxCUI: 855671 - DPH sodium 100 MG Extended Release Oral Capsule
Which are the Pharmacologic Classes for Phenytoin Sodium?
- 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)
* 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.
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* Please review the disclaimer below.
[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
[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".