topiramate

Generic: topiramate

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

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

topiramate 200 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-110
Product ID 68462-110_2068fcde-8e47-4ced-a038-b00c04dcceb8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077627
Listing Expiration 2027-12-31
Marketing Start 2009-03-27

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 68462110
Hyphenated Format 68462-110

Supplemental Identifiers

RxCUI
151226 199888 199889 199890
UPC
0368462109601 0368462153604 0368462110607
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 ANDA077627 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (68462-110-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (68462-110-10)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68462-110-60)
source: ndc

Packages (3)

68462-110-05 500 TABLET, FILM COATED in 1 BOTTLE (68462-110-05) 68462-110-10 1000 TABLET, FILM COATED in 1 BOTTLE (68462-110-10) 68462-110-60 60 TABLET, FILM COATED in 1 BOTTLE (68462-110-60)

Ingredients (1)

topiramate (200 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": "2068fcde-8e47-4ced-a038-b00c04dcceb8", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0368462109601", "0368462153604", "0368462110607"], "unii": ["0H73WJJ391"], "rxcui": ["151226", "199888", "199889", "199890"], "spl_set_id": ["35312f49-decf-428d-bf5f-4215b762ed3c"], "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": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (68462-110-05)", "package_ndc": "68462-110-05", "marketing_start_date": "20200730"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (68462-110-10)", "package_ndc": "68462-110-10", "marketing_start_date": "20090327"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68462-110-60)", "package_ndc": "68462-110-60", "marketing_start_date": "20090327"}], "brand_name": "Topiramate", "product_id": "68462-110_2068fcde-8e47-4ced-a038-b00c04dcceb8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68462-110", "generic_name": "Topiramate", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "200 mg/1"}], "application_number": "ANDA077627", "marketing_category": "ANDA", "marketing_start_date": "20090327", "listing_expiration_date": "20271231"}