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 CAPSULE
Routes
ORAL
Active Ingredients

topiramate 15 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-868
Product ID 67877-868_8dde15e5-8f0f-43bd-847f-08f5c015e4a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218482
Listing Expiration 2026-12-31
Marketing Start 2024-08-05

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 67877868
Hyphenated Format 67877-868

Supplemental Identifiers

RxCUI
205315 205316
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 ANDA218482 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE (67877-868-05)
  • 1 BLISTER PACK in 1 CARTON (67877-868-33) / 10 CAPSULE in 1 BLISTER PACK
  • 60 CAPSULE in 1 BOTTLE (67877-868-60)
source: ndc

Packages (3)

67877-868-05 500 CAPSULE in 1 BOTTLE (67877-868-05) 67877-868-33 1 BLISTER PACK in 1 CARTON (67877-868-33) / 10 CAPSULE in 1 BLISTER PACK 67877-868-60 60 CAPSULE in 1 BOTTLE (67877-868-60)

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": "8dde15e5-8f0f-43bd-847f-08f5c015e4a1", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "unii": ["0H73WJJ391"], "rxcui": ["205315", "205316"], "spl_set_id": ["cb966bcb-3af7-4dbe-b540-58d473b891e5"], "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": "500 CAPSULE in 1 BOTTLE (67877-868-05)", "package_ndc": "67877-868-05", "marketing_start_date": "20240805"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (67877-868-33)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "67877-868-33", "marketing_start_date": "20240805"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (67877-868-60)", "package_ndc": "67877-868-60", "marketing_start_date": "20240805"}], "brand_name": "Topiramate", "product_id": "67877-868_8dde15e5-8f0f-43bd-847f-08f5c015e4a1", "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": "67877-868", "generic_name": "Topiramate", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "15 mg/1"}], "application_number": "ANDA218482", "marketing_category": "ANDA", "marketing_start_date": "20240805", "listing_expiration_date": "20261231"}