topiramate

Generic: topiramate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

topiramate 200 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-712
Product ID 47335-712_3e2c55e4-3acd-4b76-9cce-5b6d0e483c4d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090278
Listing Expiration 2026-12-31
Marketing Start 2014-12-15

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 47335712
Hyphenated Format 47335-712

Supplemental Identifiers

RxCUI
151226 199888 199889 199890
UPC
0347335712865
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 ANDA090278 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (47335-712-08)
  • 500 TABLET, FILM COATED in 1 BOTTLE (47335-712-13)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (47335-712-18)
  • 30 TABLET, FILM COATED in 1 BOTTLE (47335-712-83)
  • 60 TABLET, FILM COATED in 1 BOTTLE (47335-712-86)
  • 100 TABLET, FILM COATED in 1 BOTTLE (47335-712-88)
source: ndc

Packages (6)

47335-712-08 100 TABLET, FILM COATED in 1 BOTTLE (47335-712-08) 47335-712-13 500 TABLET, FILM COATED in 1 BOTTLE (47335-712-13) 47335-712-18 1000 TABLET, FILM COATED in 1 BOTTLE (47335-712-18) 47335-712-83 30 TABLET, FILM COATED in 1 BOTTLE (47335-712-83) 47335-712-86 60 TABLET, FILM COATED in 1 BOTTLE (47335-712-86) 47335-712-88 100 TABLET, FILM COATED in 1 BOTTLE (47335-712-88)

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": "3e2c55e4-3acd-4b76-9cce-5b6d0e483c4d", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0347335712865"], "unii": ["0H73WJJ391"], "rxcui": ["151226", "199888", "199889", "199890"], "spl_set_id": ["3c909a53-ae66-4b28-a741-b60bb25a69cf"], "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": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (47335-712-08)", "package_ndc": "47335-712-08", "marketing_start_date": "20141215"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (47335-712-13)", "package_ndc": "47335-712-13", "marketing_start_date": "20141215"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (47335-712-18)", "package_ndc": "47335-712-18", "marketing_start_date": "20141215"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (47335-712-83)", "package_ndc": "47335-712-83", "marketing_start_date": "20141215"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (47335-712-86)", "package_ndc": "47335-712-86", "marketing_start_date": "20141215"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (47335-712-88)", "package_ndc": "47335-712-88", "marketing_start_date": "20141215"}], "brand_name": "Topiramate", "product_id": "47335-712_3e2c55e4-3acd-4b76-9cce-5b6d0e483c4d", "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": "47335-712", "generic_name": "Topiramate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "200 mg/1"}], "application_number": "ANDA090278", "marketing_category": "ANDA", "marketing_start_date": "20141215", "listing_expiration_date": "20261231"}