phenytoin sodium

Generic: phenytoin sodium

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenytoin sodium
Generic Name phenytoin sodium
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

phenytoin sodium 100 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-869
Product ID 71610-869_29b8a9bb-8e99-a599-e063-6394a90ab307
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040684
Listing Expiration 2026-12-31
Marketing Start 2006-09-05

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 71610869
Hyphenated Format 71610-869

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 phenytoin sodium (source: ndc)
Generic Name phenytoin sodium (source: ndc)
Application Number ANDA040684 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 270 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71610-869-92)
  • 360 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71610-869-94)
  • 540 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71610-869-98)
source: ndc

Packages (3)

71610-869-92 270 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71610-869-92) 71610-869-94 360 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71610-869-94) 71610-869-98 540 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71610-869-98)

Ingredients (1)

phenytoin sodium (100 mg/1)

Linked Drug Pages (1)

Phenytoin Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "29b8a9bb-8e99-a599-e063-6394a90ab307", "openfda": {"unii": ["4182431BJH"], "rxcui": ["855671"], "spl_set_id": ["29b8d0a2-a96e-46a5-e063-6394a90a7113"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "270 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71610-869-92)", "package_ndc": "71610-869-92", "marketing_start_date": "20241211"}, {"sample": false, "description": "360 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71610-869-94)", "package_ndc": "71610-869-94", "marketing_start_date": "20241211"}, {"sample": false, "description": "540 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71610-869-98)", "package_ndc": "71610-869-98", "marketing_start_date": "20241211"}], "brand_name": "Phenytoin Sodium", "product_id": "71610-869_29b8a9bb-8e99-a599-e063-6394a90ab307", "dosage_form": "CAPSULE, EXTENDED RELEASE", "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": "71610-869", "generic_name": "Phenytoin Sodium", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenytoin Sodium", "active_ingredients": [{"name": "PHENYTOIN SODIUM", "strength": "100 mg/1"}], "application_number": "ANDA040684", "marketing_category": "ANDA", "marketing_start_date": "20060905", "listing_expiration_date": "20261231"}