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

phenytoin sodium 100 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-479
Product ID 71610-479_444cd2c3-a0d4-4c73-b74e-284a212f288b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040765
Listing Expiration 2026-12-31
Marketing Start 2020-08-25

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 71610479
Hyphenated Format 71610-479

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 ANDA040765 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE (71610-479-60)
  • 120 CAPSULE in 1 BOTTLE (71610-479-70)
  • 270 CAPSULE in 1 BOTTLE (71610-479-92)
  • 360 CAPSULE in 1 BOTTLE (71610-479-94)
  • 540 CAPSULE in 1 BOTTLE (71610-479-98)
source: ndc

Packages (5)

71610-479-60 90 CAPSULE in 1 BOTTLE (71610-479-60) 71610-479-70 120 CAPSULE in 1 BOTTLE (71610-479-70) 71610-479-92 270 CAPSULE in 1 BOTTLE (71610-479-92) 71610-479-94 360 CAPSULE in 1 BOTTLE (71610-479-94) 71610-479-98 540 CAPSULE in 1 BOTTLE (71610-479-98)

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": "444cd2c3-a0d4-4c73-b74e-284a212f288b", "openfda": {"unii": ["4182431BJH"], "rxcui": ["855671"], "spl_set_id": ["f163208c-25e7-415b-ae17-9f5f5870e6e8"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71610-479-60)", "package_ndc": "71610-479-60", "marketing_start_date": "20201102"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (71610-479-70)", "package_ndc": "71610-479-70", "marketing_start_date": "20201102"}, {"sample": false, "description": "270 CAPSULE in 1 BOTTLE (71610-479-92)", "package_ndc": "71610-479-92", "marketing_start_date": "20201102"}, {"sample": false, "description": "360 CAPSULE in 1 BOTTLE (71610-479-94)", "package_ndc": "71610-479-94", "marketing_start_date": "20201102"}, {"sample": false, "description": "540 CAPSULE in 1 BOTTLE (71610-479-98)", "package_ndc": "71610-479-98", "marketing_start_date": "20201102"}], "brand_name": "Extended Phenytoin Sodium", "product_id": "71610-479_444cd2c3-a0d4-4c73-b74e-284a212f288b", "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": "71610-479", "generic_name": "Phenytoin Sodium", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Extended Phenytoin Sodium", "active_ingredients": [{"name": "PHENYTOIN SODIUM", "strength": "100 mg/1"}], "application_number": "ANDA040765", "marketing_category": "ANDA", "marketing_start_date": "20200825", "listing_expiration_date": "20261231"}