topiramate

Generic: topiramate

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler upsher-smith laboratories, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

topiramate 25 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 24979-211
Product ID 24979-211_bf831629-b5b8-41c4-9e1c-a5e6e5532144
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217694
Listing Expiration 2026-12-31
Marketing Start 2023-12-05

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 24979211
Hyphenated Format 24979-211

Supplemental Identifiers

RxCUI
205315 205316
UPC
0324979211046
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 ANDA217694 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 PACKAGE (24979-211-04)
source: ndc

Packages (1)

24979-211-04 60 CAPSULE in 1 PACKAGE (24979-211-04)

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": "bf831629-b5b8-41c4-9e1c-a5e6e5532144", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0324979211046"], "unii": ["0H73WJJ391"], "rxcui": ["205315", "205316"], "spl_set_id": ["e0d88f34-865c-441b-80e2-e814c9a7d670"], "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": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 PACKAGE (24979-211-04)", "package_ndc": "24979-211-04", "marketing_start_date": "20231205"}], "brand_name": "Topiramate", "product_id": "24979-211_bf831629-b5b8-41c4-9e1c-a5e6e5532144", "dosage_form": "CAPSULE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "24979-211", "generic_name": "Topiramate", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "25 mg/1"}], "application_number": "ANDA217694", "marketing_category": "ANDA", "marketing_start_date": "20231205", "listing_expiration_date": "20261231"}