trokendi xr

Generic: topiramate

Labeler: supernus pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name trokendi xr
Generic Name topiramate
Labeler supernus pharmaceuticals
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

topiramate 100 mg/1

Manufacturer
Supernus Pharmaceuticals

Identifiers & Regulatory

Product NDC 17772-103
Product ID 17772-103_41c182e6-f5f2-bfac-e063-6294a90a547f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA201635
Listing Expiration 2026-12-31
Marketing Start 2013-08-16

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 17772103
Hyphenated Format 17772-103

Supplemental Identifiers

RxCUI
1436239 1436245 1437278 1437280 1437283 1437285 1437288 1437290
UPC
0317772101300 0317772102307 0317772104301 0317772103304
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 trokendi xr (source: ndc)
Generic Name topiramate (source: ndc)
Application Number NDA201635 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-01)
  • 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-07)
  • 5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-103-10)
  • 7 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-103-12)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-30)
source: ndc

Packages (5)

17772-103-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-01) 17772-103-07 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-07) 17772-103-10 5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-103-10) 17772-103-12 7 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-103-12) 17772-103-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-30)

Ingredients (1)

topiramate (100 mg/1)

Linked Drug Pages (1)

Trokendi XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "41c182e6-f5f2-bfac-e063-6294a90a547f", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0317772101300", "0317772102307", "0317772104301", "0317772103304"], "unii": ["0H73WJJ391"], "rxcui": ["1436239", "1436245", "1437278", "1437280", "1437283", "1437285", "1437288", "1437290"], "spl_set_id": ["2dc7957e-a3e5-46bb-aa66-f3250f872f5e"], "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": ["Supernus Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-01)", "package_ndc": "17772-103-01", "marketing_start_date": "20130816"}, {"sample": true, "description": "7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-07)", "package_ndc": "17772-103-07", "marketing_start_date": "20200623"}, {"sample": true, "description": "5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-103-10)", "package_ndc": "17772-103-10", "marketing_start_date": "20130816"}, {"sample": true, "description": "7 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-103-12)", "package_ndc": "17772-103-12", "marketing_start_date": "20130816"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-30)", "package_ndc": "17772-103-30", "marketing_start_date": "20130816"}], "brand_name": "Trokendi XR", "product_id": "17772-103_41c182e6-f5f2-bfac-e063-6294a90a547f", "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": "17772-103", "generic_name": "topiramate", "labeler_name": "Supernus Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Trokendi XR", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "100 mg/1"}], "application_number": "NDA201635", "marketing_category": "NDA", "marketing_start_date": "20130816", "listing_expiration_date": "20261231"}