topiramate

Generic: topiramate

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler ascend laboratories, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

topiramate 25 mg/mL

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-833
Product ID 67877-833_775b5984-dab8-42b5-ab48-d1af773b4066
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217795
Listing Expiration 2026-12-31
Marketing Start 2025-07-07

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 67877833
Hyphenated Format 67877-833

Supplemental Identifiers

RxCUI
2586427
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 ANDA217795 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (67877-833-47)
  • 1 BOTTLE in 1 CARTON (67877-833-61) / 120 mL in 1 BOTTLE
source: ndc

Packages (2)

67877-833-47 473 mL in 1 BOTTLE (67877-833-47) 67877-833-61 1 BOTTLE in 1 CARTON (67877-833-61) / 120 mL in 1 BOTTLE

Ingredients (1)

topiramate (25 mg/mL)

Linked Drug Pages (2)

TOPIRAMATE ndc-match (0.9) TOPIRAMATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "775b5984-dab8-42b5-ab48-d1af773b4066", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "unii": ["0H73WJJ391"], "rxcui": ["2586427"], "spl_set_id": ["7bc4ec7a-9b83-4842-9057-e1a804b2596d"], "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": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (67877-833-47)", "package_ndc": "67877-833-47", "marketing_start_date": "20250707"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (67877-833-61)  / 120 mL in 1 BOTTLE", "package_ndc": "67877-833-61", "marketing_start_date": "20250707"}], "brand_name": "TOPIRAMATE", "product_id": "67877-833_775b5984-dab8-42b5-ab48-d1af773b4066", "dosage_form": "SOLUTION", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "67877-833", "generic_name": "TOPIRAMATE", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TOPIRAMATE", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "25 mg/mL"}], "application_number": "ANDA217795", "marketing_category": "ANDA", "marketing_start_date": "20250707", "listing_expiration_date": "20261231"}