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 50 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-864
Product ID 68382-864_7d20a70d-017f-48a4-8937-d2c746b5917c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207382
Listing Expiration 2026-12-31
Marketing Start 2024-09-10

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 68382864
Hyphenated Format 68382-864

Supplemental Identifiers

RxCUI
1436239 1437278 1437283 1437288
UPC
0368382863065 0368382358066 0368382864062
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 (68382-864-01)
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-864-05)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-864-06)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-864-16)
  • 3 BLISTER PACK in 1 CARTON (68382-864-78) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-864-30)
source: ndc

Packages (5)

68382-864-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-864-01) 68382-864-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-864-05) 68382-864-06 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-864-06) 68382-864-16 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-864-16) 68382-864-78 3 BLISTER PACK in 1 CARTON (68382-864-78) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-864-30)

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": "7d20a70d-017f-48a4-8937-d2c746b5917c", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0368382863065", "0368382358066", "0368382864062"], "unii": ["0H73WJJ391"], "rxcui": ["1436239", "1437278", "1437283", "1437288"], "spl_set_id": ["f72774dd-c7eb-41f9-9837-02baf77cc523"], "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": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-864-01)", "package_ndc": "68382-864-01", "marketing_start_date": "20240910"}, {"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-864-05)", "package_ndc": "68382-864-05", "marketing_start_date": "20240910"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-864-06)", "package_ndc": "68382-864-06", "marketing_start_date": "20240910"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-864-16)", "package_ndc": "68382-864-16", "marketing_start_date": "20240910"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (68382-864-78)  / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-864-30)", "package_ndc": "68382-864-78", "marketing_start_date": "20240910"}], "brand_name": "Topiramate", "product_id": "68382-864_7d20a70d-017f-48a4-8937-d2c746b5917c", "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": "68382-864", "generic_name": "Topiramate", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "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": "20240910", "listing_expiration_date": "20261231"}