phenytoin sodium

Generic: phenytoin sodium

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenytoin sodium
Generic Name phenytoin sodium
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

phenytoin sodium 50 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1251
Product ID 51662-1251_0f8e2789-a18e-bfe6-e063-6394a90abbe9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084307
Listing Expiration 2026-12-31
Marketing Start 2018-09-16

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 516621251
Hyphenated Format 51662-1251

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, SINGLE-DOSE (51662-1251-1)
  • 25 POUCH in 1 BOX (51662-1251-3) / 1 VIAL in 1 POUCH (51662-1251-2) / 2 mL in 1 VIAL
source: ndc

Packages (2)

51662-1251-1 2 mL in 1 VIAL, SINGLE-DOSE (51662-1251-1) 51662-1251-3 25 POUCH in 1 BOX (51662-1251-3) / 1 VIAL in 1 POUCH (51662-1251-2) / 2 mL in 1 VIAL

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": "0f8e2789-a18e-bfe6-e063-6394a90abbe9", "openfda": {"unii": ["4182431BJH"], "rxcui": ["1670351"], "spl_set_id": ["7607ddff-2f1c-272c-e053-2991aa0a1ab3"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "2 mL in 1 VIAL, SINGLE-DOSE (51662-1251-1)", "package_ndc": "51662-1251-1", "marketing_start_date": "20180916"}, {"sample": false, "description": "25 POUCH in 1 BOX (51662-1251-3)  / 1 VIAL in 1 POUCH (51662-1251-2)  / 2 mL in 1 VIAL", "package_ndc": "51662-1251-3", "marketing_start_date": "20220316"}], "brand_name": "PHENYTOIN SODIUM", "product_id": "51662-1251_0f8e2789-a18e-bfe6-e063-6394a90abbe9", "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": "51662-1251", "generic_name": "PHENYTOIN SODIUM", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "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": "20180916", "listing_expiration_date": "20261231"}