phenytoin sodium

Generic: phenytoin sodium

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenytoin sodium
Generic Name phenytoin sodium
Labeler propharma distribution
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

phenytoin sodium 50 mg/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-093
Product ID 84549-093_43060ca9-58a6-3371-e063-6294a90a5799
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084307
Listing Expiration 2026-12-31
Marketing Start 1975-07-16

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 84549093
Hyphenated Format 84549-093

Supplemental Identifiers

RxCUI
1670351
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 ANDA084307 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 2 mL in 1 VIAL (84549-093-25)
source: ndc

Packages (1)

84549-093-25 2 mL in 1 VIAL (84549-093-25)

Ingredients (1)

phenytoin sodium (50 mg/mL)

Linked Drug Pages (1)

Phenytoin Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "43060ca9-58a6-3371-e063-6294a90a5799", "openfda": {"unii": ["4182431BJH"], "rxcui": ["1670351"], "spl_set_id": ["43060ca9-58a7-3371-e063-6294a90a5799"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "2 mL in 1 VIAL (84549-093-25)", "package_ndc": "84549-093-25", "marketing_start_date": "20251010"}], "brand_name": "Phenytoin Sodium", "product_id": "84549-093_43060ca9-58a6-3371-e063-6294a90a5799", "dosage_form": "INJECTION", "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": "84549-093", "generic_name": "Phenytoin Sodium", "labeler_name": "ProPharma Distribution", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenytoin Sodium", "active_ingredients": [{"name": "PHENYTOIN SODIUM", "strength": "50 mg/mL"}], "application_number": "ANDA084307", "marketing_category": "ANDA", "marketing_start_date": "19750716", "listing_expiration_date": "20261231"}