topiramate

Generic: topiramate

Labeler: c
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler c
Dosage Form TABLET
Routes
ORAL
Active Ingredients

topiramate 100 mg/1

Manufacturer
C

Identifiers & Regulatory

Product NDC 61919-213
Product ID 61919-213_4c490e55-407d-a23d-e063-6394a90ac099
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076343
Listing Expiration 2027-12-31
Marketing Start 2024-04-17

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 61919213
Hyphenated Format 61919-213

Supplemental Identifiers

RxCUI
199889
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 ANDA076343 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (61919-213-30)
  • 60 TABLET in 1 BOTTLE (61919-213-60)
  • 120 TABLET in 1 BOTTLE (61919-213-72)
  • 90 TABLET in 1 BOTTLE (61919-213-90)
source: ndc

Packages (4)

61919-213-30 30 TABLET in 1 BOTTLE (61919-213-30) 61919-213-60 60 TABLET in 1 BOTTLE (61919-213-60) 61919-213-72 120 TABLET in 1 BOTTLE (61919-213-72) 61919-213-90 90 TABLET in 1 BOTTLE (61919-213-90)

Ingredients (1)

topiramate (100 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": "4c490e55-407d-a23d-e063-6394a90ac099", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "unii": ["0H73WJJ391"], "rxcui": ["199889"], "spl_set_id": ["164cb1f7-1a41-675f-e063-6294a90ae0dd"], "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": ["C"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (61919-213-30)", "package_ndc": "61919-213-30", "marketing_start_date": "20240417"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (61919-213-60)", "package_ndc": "61919-213-60", "marketing_start_date": "20240417"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (61919-213-72)", "package_ndc": "61919-213-72", "marketing_start_date": "20240417"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (61919-213-90)", "package_ndc": "61919-213-90", "marketing_start_date": "20240417"}], "brand_name": "Topiramate", "product_id": "61919-213_4c490e55-407d-a23d-e063-6394a90ac099", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "61919-213", "generic_name": "Topiramate", "labeler_name": "C", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "100 mg/1"}], "application_number": "ANDA076343", "marketing_category": "ANDA", "marketing_start_date": "20240417", "listing_expiration_date": "20271231"}