extended phenytoin sodium

Generic: phenytoin sodium

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name extended phenytoin sodium
Generic Name phenytoin sodium
Labeler aurobindo pharma limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

phenytoin sodium 100 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-692
Product ID 65862-692_8b54186e-7485-40f0-8fe0-58b417dfcb7e
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 65862692
Hyphenated Format 65862-692

Supplemental Identifiers

RxCUI
855671
UNII
4182431BJH

Packaging Origin

Original Packager
true

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
  • 100 CAPSULE in 1 BOTTLE (65862-692-01)
  • 10 BLISTER PACK in 1 CARTON (65862-692-78) / 10 CAPSULE in 1 BLISTER PACK (65862-692-10)
  • 1000 CAPSULE in 1 BOTTLE (65862-692-99)
source: ndc

Packages (3)

65862-692-01 100 CAPSULE in 1 BOTTLE (65862-692-01) 65862-692-78 10 BLISTER PACK in 1 CARTON (65862-692-78) / 10 CAPSULE in 1 BLISTER PACK (65862-692-10) 65862-692-99 1000 CAPSULE in 1 BOTTLE (65862-692-99)

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": "8b54186e-7485-40f0-8fe0-58b417dfcb7e", "openfda": {"unii": ["4182431BJH"], "rxcui": ["855671"], "spl_set_id": ["5362ea50-38a4-48b4-a85b-d634c3d8b91a"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (65862-692-01)", "package_ndc": "65862-692-01", "marketing_start_date": "20150610"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-692-78)  / 10 CAPSULE in 1 BLISTER PACK (65862-692-10)", "package_ndc": "65862-692-78", "marketing_start_date": "20150610"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (65862-692-99)", "package_ndc": "65862-692-99", "marketing_start_date": "20150610"}], "brand_name": "Extended Phenytoin Sodium", "product_id": "65862-692_8b54186e-7485-40f0-8fe0-58b417dfcb7e", "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": "65862-692", "generic_name": "Phenytoin Sodium", "labeler_name": "Aurobindo Pharma Limited", "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"}