topiramate

Generic: topiramate

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

topiramate 50 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-5165
Product ID 68071-5165_1b565e10-f520-1a35-e063-6294a90ae2e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090278
Listing Expiration 2026-12-31
Marketing Start 2014-12-15

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 680715165
Hyphenated Format 68071-5165

Supplemental Identifiers

RxCUI
151226
UPC
0368071516562
UNII
0H73WJJ391
NUI
N0000008486 N0000185506 N0000182140

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 topiramate (source: ndc)
Generic Name topiramate (source: ndc)
Application Number ANDA090278 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (68071-5165-6)
source: ndc

Packages (1)

68071-5165-6 60 TABLET, FILM COATED in 1 BOTTLE (68071-5165-6)

Ingredients (1)

topiramate (50 mg/1)

Linked Drug Pages (1)

Topiramate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1b565e10-f520-1a35-e063-6294a90ae2e2", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0368071516562"], "unii": ["0H73WJJ391"], "rxcui": ["151226"], "spl_set_id": ["9ddb8451-a455-87ec-e053-2995a90a5e5e"], "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": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68071-5165-6)", "package_ndc": "68071-5165-6", "marketing_start_date": "20200205"}], "brand_name": "Topiramate", "product_id": "68071-5165_1b565e10-f520-1a35-e063-6294a90ae2e2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68071-5165", "generic_name": "Topiramate", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "50 mg/1"}], "application_number": "ANDA090278", "marketing_category": "ANDA", "marketing_start_date": "20141215", "listing_expiration_date": "20261231"}