phenytoin sodium

Generic: phenytoin sodium

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenytoin sodium
Generic Name phenytoin sodium
Labeler remedyrepack inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

phenytoin sodium 100 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-2293
Product ID 70518-2293_49f0fba1-e922-aee8-e063-6394a90a8d75
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040684
Listing Expiration 2027-12-31
Marketing Start 2019-09-03

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 705182293
Hyphenated Format 70518-2293

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 phenytoin sodium (source: ndc)
Generic Name phenytoin sodium (source: ndc)
Application Number ANDA040684 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-2293-0)
  • 100 POUCH in 1 BOX (70518-2293-1) / 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-2293-2)
source: ndc

Packages (2)

70518-2293-0 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-2293-0) 70518-2293-1 100 POUCH in 1 BOX (70518-2293-1) / 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-2293-2)

Ingredients (1)

phenytoin sodium (100 mg/1)

Linked Drug Pages (1)

Phenytoin Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "49f0fba1-e922-aee8-e063-6394a90a8d75", "openfda": {"unii": ["4182431BJH"], "rxcui": ["855671"], "spl_set_id": ["844a16db-17d5-44da-819d-54f3e19cfec2"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-2293-0)", "package_ndc": "70518-2293-0", "marketing_start_date": "20190903"}, {"sample": false, "description": "100 POUCH in 1 BOX (70518-2293-1)  / 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-2293-2)", "package_ndc": "70518-2293-1", "marketing_start_date": "20210805"}], "brand_name": "Phenytoin Sodium", "product_id": "70518-2293_49f0fba1-e922-aee8-e063-6394a90a8d75", "dosage_form": "CAPSULE, EXTENDED RELEASE", "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": "70518-2293", "generic_name": "Phenytoin Sodium", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenytoin Sodium", "active_ingredients": [{"name": "PHENYTOIN SODIUM", "strength": "100 mg/1"}], "application_number": "ANDA040684", "marketing_category": "ANDA", "marketing_start_date": "20190903", "listing_expiration_date": "20271231"}