phenytoin

Generic: phenytoin

Labeler: atlantic biologicals corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenytoin
Generic Name phenytoin
Labeler atlantic biologicals corp.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

phenytoin 125 mg/5mL

Manufacturer
ATLANTIC BIOLOGICALS CORP.

Identifiers & Regulatory

Product NDC 17856-4070
Product ID 17856-4070_36335944-2d3c-b82e-e063-6294a90a705c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040521
Listing Expiration 2026-12-31
Marketing Start 2004-04-08

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]
Mechanism of Action
cytochrome p450 1a2 inducers [moa] cytochrome p450 2b6 inducers [moa] cytochrome p450 2c8 inducers [moa] cytochrome p450 2c19 inducers [moa] cytochrome p450 2d6 inducers [moa] cytochrome p450 3a inducers [moa] cytochrome p450 2c9 inducers [moa]
Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 178564070
Hyphenated Format 17856-4070

Supplemental Identifiers

RxCUI
1313112
UNII
6158TKW0C5
NUI
N0000175753 N0000008486 N0000191266 N0000187064 N0000187063 N0000185607 N0000191267 N0000190118 N0000185507

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 (source: ndc)
Generic Name phenytoin (source: ndc)
Application Number ANDA040521 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/5mL
source: ndc
Packaging
  • 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-4070-1) / 4 mL in 1 CUP, UNIT-DOSE (17856-4070-2)
source: ndc

Packages (1)

17856-4070-1 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-4070-1) / 4 mL in 1 CUP, UNIT-DOSE (17856-4070-2)

Ingredients (1)

phenytoin (125 mg/5mL)

Linked Drug Pages (1)

Phenytoin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "36335944-2d3c-b82e-e063-6294a90a705c", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000191266", "N0000187064", "N0000187063", "N0000185607", "N0000191267", "N0000190118", "N0000185507"], "unii": ["6158TKW0C5"], "rxcui": ["1313112"], "spl_set_id": ["09daf485-3355-44cb-92af-072dd281e129"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "pharm_class_moa": ["Cytochrome P450 1A2 Inducers [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Cytochrome P450 2C8 Inducers [MoA]", "Cytochrome P450 2C19 Inducers [MoA]", "Cytochrome P450 2D6 Inducers [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Cytochrome P450 2C9 Inducers [MoA]"], "manufacturer_name": ["ATLANTIC BIOLOGICALS CORP."]}, "finished": true, "packaging": [{"sample": false, "description": "72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-4070-1)  / 4 mL in 1 CUP, UNIT-DOSE (17856-4070-2)", "package_ndc": "17856-4070-1", "marketing_start_date": "20240509"}], "brand_name": "Phenytoin", "product_id": "17856-4070_36335944-2d3c-b82e-e063-6294a90a705c", "dosage_form": "SUSPENSION", "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": "17856-4070", "generic_name": "Phenytoin", "labeler_name": "ATLANTIC BIOLOGICALS CORP.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenytoin", "active_ingredients": [{"name": "PHENYTOIN", "strength": "125 mg/5mL"}], "application_number": "ANDA040521", "marketing_category": "ANDA", "marketing_start_date": "20040408", "listing_expiration_date": "20261231"}