phenytoin sodium

Generic: phenytoin sodium

Labeler: acella pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenytoin sodium
Generic Name phenytoin sodium
Labeler acella pharmaceuticals, llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

phenytoin sodium 50 mg/mL

Manufacturer
Acella Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 42192-614
Product ID 42192-614_ae14cce7-f65a-45e0-8ff4-9388d0a806d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040573
Listing Expiration 2026-12-31
Marketing Start 2021-12-01

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 42192614
Hyphenated Format 42192-614

Supplemental Identifiers

RxCUI
1670351 1670353
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 phenytoin sodium (source: ndc)
Generic Name phenytoin sodium (source: ndc)
Application Number ANDA040573 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (42192-614-10) / 2 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (42192-614-30) / 5 mL in 1 VIAL
source: ndc

Packages (2)

42192-614-10 10 VIAL in 1 CARTON (42192-614-10) / 2 mL in 1 VIAL 42192-614-30 10 VIAL in 1 CARTON (42192-614-30) / 5 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": "ae14cce7-f65a-45e0-8ff4-9388d0a806d2", "openfda": {"unii": ["4182431BJH"], "rxcui": ["1670351", "1670353"], "spl_set_id": ["6922f32f-8bed-4c09-8103-27987bcbd104"], "manufacturer_name": ["Acella Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (42192-614-10)  / 2 mL in 1 VIAL", "package_ndc": "42192-614-10", "marketing_start_date": "20211230"}, {"sample": false, "description": "10 VIAL in 1 CARTON (42192-614-30)  / 5 mL in 1 VIAL", "package_ndc": "42192-614-30", "marketing_start_date": "20211230"}], "brand_name": "PHENYTOIN SODIUM", "product_id": "42192-614_ae14cce7-f65a-45e0-8ff4-9388d0a806d2", "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": "42192-614", "generic_name": "PHENYTOIN SODIUM", "labeler_name": "Acella Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PHENYTOIN SODIUM", "active_ingredients": [{"name": "PHENYTOIN SODIUM", "strength": "50 mg/mL"}], "application_number": "ANDA040573", "marketing_category": "ANDA", "marketing_start_date": "20211201", "listing_expiration_date": "20261231"}