topiramate

Generic: topiramate

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

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler teva pharmaceuticals, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

topiramate 50 mg/1

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-2357
Product ID 0480-2357_38168585-df97-4809-8f00-a61122c7259f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206210
Listing Expiration 2027-12-31
Marketing Start 2023-05-03

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 04802357
Hyphenated Format 0480-2357

Supplemental Identifiers

RxCUI
1436239 1437278 1437283 1437288
UPC
0304802359565 0304802356564 0304802358568 0304802357561
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 topiramate (source: ndc)
Generic Name topiramate (source: ndc)
Application Number ANDA206210 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-2357-01)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-2357-56)
source: ndc

Packages (2)

0480-2357-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-2357-01) 0480-2357-56 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-2357-56)

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": "38168585-df97-4809-8f00-a61122c7259f", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0304802359565", "0304802356564", "0304802358568", "0304802357561"], "unii": ["0H73WJJ391"], "rxcui": ["1436239", "1437278", "1437283", "1437288"], "spl_set_id": ["4f20155f-05b9-40ec-af34-3b58aa8d60d4"], "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": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-2357-01)", "package_ndc": "0480-2357-01", "marketing_start_date": "20230503"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-2357-56)", "package_ndc": "0480-2357-56", "marketing_start_date": "20230503"}], "brand_name": "Topiramate", "product_id": "0480-2357_38168585-df97-4809-8f00-a61122c7259f", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "0480-2357", "generic_name": "Topiramate", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "50 mg/1"}], "application_number": "ANDA206210", "marketing_category": "ANDA", "marketing_start_date": "20230503", "listing_expiration_date": "20271231"}