topamax

Generic: topiramate

Labeler: janssen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name topamax
Generic Name topiramate
Labeler janssen pharmaceuticals, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

topiramate 50 mg/1

Manufacturer
Janssen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50458-640
Product ID 50458-640_24a60ffa-e7bf-4987-8416-a9b8ac82e6ec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020505
Listing Expiration 2027-12-31
Marketing Start 1997-01-01

Pharmacologic Class

Mechanism of Action
cytochrome p450 3a4 inducers [moa] cytochrome p450 2c19 inhibitors [moa]
Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50458640
Hyphenated Format 50458-640

Supplemental Identifiers

RxCUI
151226 151227 151228 151229 152855 199888 199889 199890 205315 205316 845478 845479
UPC
0350458647655 0350458641653 0350458645651 0350458639650 0350458640656 0350458642650
UNII
0H73WJJ391
NUI
N0000008486 N0000185506 N0000182140

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 topamax (source: ndc)
Generic Name topiramate (source: ndc)
Application Number NDA020505 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 60 TABLET, COATED in 1 BOTTLE (50458-640-65)
source: ndc

Packages (1)

50458-640-65 60 TABLET, COATED in 1 BOTTLE (50458-640-65)

Ingredients (1)

topiramate (50 mg/1)

Linked Drug Pages (1)

Topamax ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "24a60ffa-e7bf-4987-8416-a9b8ac82e6ec", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0350458647655", "0350458641653", "0350458645651", "0350458639650", "0350458640656", "0350458642650"], "unii": ["0H73WJJ391"], "rxcui": ["151226", "151227", "151228", "151229", "152855", "199888", "199889", "199890", "205315", "205316", "845478", "845479"], "spl_set_id": ["21628112-0c47-11df-95b3-498d55d89593"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_moa": ["Cytochrome P450 3A4 Inducers [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Janssen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (50458-640-65)", "package_ndc": "50458-640-65", "marketing_start_date": "19970101"}], "brand_name": "Topamax", "product_id": "50458-640_24a60ffa-e7bf-4987-8416-a9b8ac82e6ec", "dosage_form": "TABLET, COATED", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "50458-640", "generic_name": "topiramate", "labeler_name": "Janssen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topamax", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "50 mg/1"}], "application_number": "NDA020505", "marketing_category": "NDA", "marketing_start_date": "19970101", "listing_expiration_date": "20271231"}