topiramate

Generic: topiramate spinkle

Labeler: heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate spinkle
Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

topiramate 15 mg/1

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 23155-894
Product ID 23155-894_c6498e0a-7dbe-4132-897b-a2721fb2190c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078418
Marketing Start 2024-02-16
Marketing End 2026-08-31

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 23155894
Hyphenated Format 23155-894

Supplemental Identifiers

RxCUI
205315 205316
UPC
0323155895063 0323155894066
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 spinkle (source: ndc)
Application Number ANDA078418 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (23155-894-06)
source: ndc

Packages (1)

23155-894-06 60 CAPSULE in 1 BOTTLE (23155-894-06)

Ingredients (1)

topiramate (15 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": "c6498e0a-7dbe-4132-897b-a2721fb2190c", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0323155895063", "0323155894066"], "unii": ["0H73WJJ391"], "rxcui": ["205315", "205316"], "spl_set_id": ["1730870d-e661-41f9-bd0d-d8daaf087819"], "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": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (23155-894-06)", "package_ndc": "23155-894-06", "marketing_end_date": "20260831", "marketing_start_date": "20240216"}], "brand_name": "TOPIRAMATE", "product_id": "23155-894_c6498e0a-7dbe-4132-897b-a2721fb2190c", "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": "23155-894", "generic_name": "topiramate spinkle", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TOPIRAMATE", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "15 mg/1"}], "application_number": "ANDA078418", "marketing_category": "ANDA", "marketing_end_date": "20260831", "marketing_start_date": "20240216"}