topiramate

Generic: topiramate

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

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler endo usa, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

topiramate 200 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 10370-368
Product ID 10370-368_d2a47bf0-9716-4318-9f8c-bd3d43c0637f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205976
Listing Expiration 2026-12-31
Marketing Start 2023-03-24

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 10370368
Hyphenated Format 10370-368

Supplemental Identifiers

RxCUI
1437288
UPC
0310370368113
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 ANDA205976 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-368-01)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-368-11)
source: ndc

Packages (2)

10370-368-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-368-01) 10370-368-11 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-368-11)

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": "d2a47bf0-9716-4318-9f8c-bd3d43c0637f", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0310370368113"], "unii": ["0H73WJJ391"], "rxcui": ["1437288"], "spl_set_id": ["9ac09563-5967-498c-93ae-675a7f4efc48"], "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": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-368-01)", "package_ndc": "10370-368-01", "marketing_start_date": "20230324"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-368-11)", "package_ndc": "10370-368-11", "marketing_start_date": "20230324"}], "brand_name": "Topiramate", "product_id": "10370-368_d2a47bf0-9716-4318-9f8c-bd3d43c0637f", "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": "10370-368", "generic_name": "Topiramate", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "200 mg/1"}], "application_number": "ANDA205976", "marketing_category": "ANDA", "marketing_start_date": "20230324", "listing_expiration_date": "20261231"}