topiramate

Generic: topiramate

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

topiramate 100 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1041
Product ID 70710-1041_2789fa8f-bb3b-4c35-a665-53efc476258d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208949
Listing Expiration 2026-12-31
Marketing Start 2023-01-17

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 707101041
Hyphenated Format 70710-1041

Supplemental Identifiers

RxCUI
1494769 1812419 1812421 1812425 1812427
UPC
0370710104139 0370710104030 0370710104337 0370710103934 0370710104238
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 ANDA208949 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1041-3)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1041-9)
source: ndc

Packages (2)

70710-1041-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1041-3) 70710-1041-9 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1041-9)

Ingredients (1)

topiramate (100 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": "2789fa8f-bb3b-4c35-a665-53efc476258d", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0370710104139", "0370710104030", "0370710104337", "0370710103934", "0370710104238"], "unii": ["0H73WJJ391"], "rxcui": ["1494769", "1812419", "1812421", "1812425", "1812427"], "spl_set_id": ["a5ca2fce-bd2d-40db-b963-e3ec27c8bf23"], "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": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1041-3)", "package_ndc": "70710-1041-3", "marketing_start_date": "20230117"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1041-9)", "package_ndc": "70710-1041-9", "marketing_start_date": "20230117"}], "brand_name": "Topiramate", "product_id": "70710-1041_2789fa8f-bb3b-4c35-a665-53efc476258d", "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": "70710-1041", "generic_name": "Topiramate", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "100 mg/1"}], "application_number": "ANDA208949", "marketing_category": "ANDA", "marketing_start_date": "20230117", "listing_expiration_date": "20261231"}