topiramate

Generic: topiramate

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler zydus lifesciences limited
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

topiramate 50 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1316
Product ID 70771-1316_709dd70b-24e1-435f-8373-02e6dd538b2c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207382
Listing Expiration 2026-12-31
Marketing Start 2018-04-05

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 707711316
Hyphenated Format 70771-1316

Supplemental Identifiers

RxCUI
1436239 1437278 1437283 1437288
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 ANDA207382 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1316-1)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1316-3)
  • 10 BLISTER PACK in 1 CARTON (70771-1316-4) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70771-1316-2)
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1316-5)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1316-9)
source: ndc

Packages (5)

70771-1316-1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1316-1) 70771-1316-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1316-3) 70771-1316-4 10 BLISTER PACK in 1 CARTON (70771-1316-4) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70771-1316-2) 70771-1316-5 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1316-5) 70771-1316-9 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1316-9)

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": "709dd70b-24e1-435f-8373-02e6dd538b2c", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "unii": ["0H73WJJ391"], "rxcui": ["1436239", "1437278", "1437283", "1437288"], "spl_set_id": ["9a943af0-1c6d-43c2-830a-f303baa16124"], "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 Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1316-1)", "package_ndc": "70771-1316-1", "marketing_start_date": "20180405"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1316-3)", "package_ndc": "70771-1316-3", "marketing_start_date": "20180405"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1316-4)  / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70771-1316-2)", "package_ndc": "70771-1316-4", "marketing_start_date": "20180405"}, {"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1316-5)", "package_ndc": "70771-1316-5", "marketing_start_date": "20180405"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1316-9)", "package_ndc": "70771-1316-9", "marketing_start_date": "20180405"}], "brand_name": "Topiramate", "product_id": "70771-1316_709dd70b-24e1-435f-8373-02e6dd538b2c", "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": "70771-1316", "generic_name": "Topiramate", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "50 mg/1"}], "application_number": "ANDA207382", "marketing_category": "ANDA", "marketing_start_date": "20180405", "listing_expiration_date": "20261231"}