topiramate

Generic: topiramate

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler upsher-smith laboratories, llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

topiramate 25 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-1071
Product ID 0832-1071_4c23c6e3-1684-b1fd-e063-6394a90a99a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA205122
Listing Expiration 2027-12-31
Marketing Start 2014-07-07

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 08321071
Hyphenated Format 0832-1071

Supplemental Identifiers

RxCUI
1494769 1812419 1812421 1812425 1812427
UPC
0308321072301 0308321074305
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 NDA205122 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-1071-15)
  • 1 BOTTLE in 1 CARTON (0832-1071-30) / 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0832-1071-90) / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
source: ndc

Packages (3)

0832-1071-15 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-1071-15) 0832-1071-30 1 BOTTLE in 1 CARTON (0832-1071-30) / 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE 0832-1071-90 1 BOTTLE in 1 CARTON (0832-1071-90) / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

Ingredients (1)

topiramate (25 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": "4c23c6e3-1684-b1fd-e063-6394a90a99a6", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0308321072301", "0308321074305"], "unii": ["0H73WJJ391"], "rxcui": ["1494769", "1812419", "1812421", "1812425", "1812427"], "spl_set_id": ["691d276c-9cc1-4d39-828f-0f44d7ef6328"], "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": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-1071-15)", "package_ndc": "0832-1071-15", "marketing_start_date": "20140707"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0832-1071-30)  / 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "0832-1071-30", "marketing_start_date": "20140707"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0832-1071-90)  / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "0832-1071-90", "marketing_start_date": "20140707"}], "brand_name": "Topiramate", "product_id": "0832-1071_4c23c6e3-1684-b1fd-e063-6394a90a99a6", "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": "0832-1071", "generic_name": "Topiramate", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "25 mg/1"}], "application_number": "NDA205122", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20140707", "listing_expiration_date": "20271231"}