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, COATED PELLETS
Routes
ORAL
Active Ingredients

topiramate 15 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-004
Product ID 68382-004_a5fb1350-e27f-43ba-ba26-a28fd3941f8a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078877
Listing Expiration 2026-12-31
Marketing Start 2009-10-14

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 68382004
Hyphenated Format 68382-004

Supplemental Identifiers

RxCUI
205315 205316 252413
UPC
0368382005144
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 ANDA078877 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 100 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-01)
  • 500 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-05)
  • 1000 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-10)
  • 60 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-14)
  • 90 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-16)
source: ndc

Packages (5)

68382-004-01 100 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-01) 68382-004-05 500 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-05) 68382-004-10 1000 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-10) 68382-004-14 60 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-14) 68382-004-16 90 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-16)

Ingredients (1)

topiramate (15 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": "a5fb1350-e27f-43ba-ba26-a28fd3941f8a", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0368382005144"], "unii": ["0H73WJJ391"], "rxcui": ["205315", "205316", "252413"], "spl_set_id": ["e4886adf-199d-4b19-a4ef-75f8f94cb54e"], "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, COATED PELLETS in 1 BOTTLE (68382-004-01)", "package_ndc": "68382-004-01", "marketing_start_date": "20091014"}, {"sample": false, "description": "500 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-05)", "package_ndc": "68382-004-05", "marketing_start_date": "20091014"}, {"sample": false, "description": "1000 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-10)", "package_ndc": "68382-004-10", "marketing_start_date": "20091014"}, {"sample": false, "description": "60 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-14)", "package_ndc": "68382-004-14", "marketing_start_date": "20091014"}, {"sample": false, "description": "90 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-16)", "package_ndc": "68382-004-16", "marketing_start_date": "20091014"}], "brand_name": "topiramate", "product_id": "68382-004_a5fb1350-e27f-43ba-ba26-a28fd3941f8a", "dosage_form": "CAPSULE, COATED PELLETS", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68382-004", "generic_name": "topiramate", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "15 mg/1"}], "application_number": "ANDA078877", "marketing_category": "ANDA", "marketing_start_date": "20091014", "listing_expiration_date": "20261231"}