dilantin

Generic: extended phenytoin sodium

Labeler: parke-davis div of pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dilantin
Generic Name extended phenytoin sodium
Labeler parke-davis div of pfizer inc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

phenytoin sodium 100 mg/1

Manufacturer
Parke-Davis Div of Pfizer Inc

Identifiers & Regulatory

Product NDC 0071-0369
Product ID 0071-0369_3696853c-9eef-4f2f-8b97-e0df56431698
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084349
Marketing Start 1976-08-27
Marketing End 2026-03-31

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 00710369
Hyphenated Format 0071-0369

Supplemental Identifiers

RxCUI
855671 855673 855869 855871
UPC
0300710369245
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 dilantin (source: ndc)
Generic Name extended phenytoin sodium (source: ndc)
Application Number ANDA084349 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1000 CAPSULE in 1 BOTTLE (0071-0369-32)
source: ndc

Packages (1)

0071-0369-32 1000 CAPSULE in 1 BOTTLE (0071-0369-32)

Ingredients (1)

phenytoin sodium (100 mg/1)

Linked Drug Pages (1)

Dilantin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3696853c-9eef-4f2f-8b97-e0df56431698", "openfda": {"upc": ["0300710369245"], "unii": ["4182431BJH"], "rxcui": ["855671", "855673", "855869", "855871"], "spl_set_id": ["8848de76-8d74-4620-bcc7-a86a596e5dd9"], "manufacturer_name": ["Parke-Davis Div of Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (0071-0369-32)", "package_ndc": "0071-0369-32", "marketing_end_date": "20260331", "marketing_start_date": "19760827"}], "brand_name": "Dilantin", "product_id": "0071-0369_3696853c-9eef-4f2f-8b97-e0df56431698", "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": "0071-0369", "generic_name": "Extended Phenytoin Sodium", "labeler_name": "Parke-Davis Div of Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dilantin", "active_ingredients": [{"name": "PHENYTOIN SODIUM", "strength": "100 mg/1"}], "application_number": "ANDA084349", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "19760827"}