extended phenytoin sodium

Generic: phenytoin sodium

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name extended phenytoin sodium
Generic Name phenytoin sodium
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

phenytoin sodium 100 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8556
Product ID 0615-8556_8240390a-9bc8-4256-8f2a-107c97c0400c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204309
Listing Expiration 2026-12-31
Marketing Start 2015-06-10

Pharmacologic Class

Classes
anti-epileptic agent [epc] cytochrome p450 1a2 inducers [moa] cytochrome p450 2b6 inducers [moa] cytochrome p450 2c19 inducers [moa] cytochrome p450 2c8 inducers [moa] cytochrome p450 2c9 inducers [moa] cytochrome p450 2d6 inducers [moa] cytochrome p450 3a inducers [moa] decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06158556
Hyphenated Format 0615-8556

Supplemental Identifiers

RxCUI
855671
UNII
4182431BJH

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name extended phenytoin sodium (source: ndc)
Generic Name phenytoin sodium (source: ndc)
Application Number ANDA204309 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BLISTER PACK (0615-8556-39)
source: ndc

Packages (1)

0615-8556-39 30 CAPSULE in 1 BLISTER PACK (0615-8556-39)

Ingredients (1)

phenytoin sodium (100 mg/1)

Linked Drug Pages (1)

Extended Phenytoin Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8240390a-9bc8-4256-8f2a-107c97c0400c", "openfda": {"unii": ["4182431BJH"], "rxcui": ["855671"], "spl_set_id": ["a7bfb3aa-5226-4a48-8156-a9ecc4536fdf"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (0615-8556-39)", "package_ndc": "0615-8556-39", "marketing_start_date": "20241016"}], "brand_name": "Extended Phenytoin Sodium", "product_id": "0615-8556_8240390a-9bc8-4256-8f2a-107c97c0400c", "dosage_form": "CAPSULE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Cytochrome P450 1A2 Inducers [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Cytochrome P450 2C19 Inducers [MoA]", "Cytochrome P450 2C8 Inducers [MoA]", "Cytochrome P450 2C9 Inducers [MoA]", "Cytochrome P450 2D6 Inducers [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "0615-8556", "generic_name": "Phenytoin Sodium", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Extended Phenytoin Sodium", "active_ingredients": [{"name": "PHENYTOIN SODIUM", "strength": "100 mg/1"}], "application_number": "ANDA204309", "marketing_category": "ANDA", "marketing_start_date": "20150610", "listing_expiration_date": "20261231"}