topiramate

Generic: topiramate

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler avkare
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

topiramate 25 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-955
Product ID 42291-955_48c104bb-d8d9-2940-e063-6394a90aeab3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206210
Listing Expiration 2027-12-31
Marketing Start 2024-10-30

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 42291955
Hyphenated Format 42291-955

Supplemental Identifiers

RxCUI
1436239 1437278 1437283 1437288
UPC
0342291958302 0342291957305 0342291956308
UNII
0H73WJJ391
NUI
N0000008486 N0000185506 N0000182140

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 ANDA206210 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-955-30)
source: ndc

Packages (1)

42291-955-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-955-30)

Ingredients (1)

topiramate (25 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": "48c104bb-d8d9-2940-e063-6394a90aeab3", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0342291958302", "0342291957305", "0342291956308"], "unii": ["0H73WJJ391"], "rxcui": ["1436239", "1437278", "1437283", "1437288"], "spl_set_id": ["25b377f7-ea89-fb56-e063-6394a90a239d"], "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": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-955-30)", "package_ndc": "42291-955-30", "marketing_start_date": "20241030"}], "brand_name": "Topiramate", "product_id": "42291-955_48c104bb-d8d9-2940-e063-6394a90aeab3", "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": "42291-955", "generic_name": "Topiramate", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "25 mg/1"}], "application_number": "ANDA206210", "marketing_category": "ANDA", "marketing_start_date": "20241030", "listing_expiration_date": "20271231"}