topiramate

Generic: topiramate

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

topiramate 50 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-734
Product ID 43063-734_39f9738a-570e-d6a6-e063-6294a90ac1ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076343
Listing Expiration 2026-12-31
Marketing Start 2014-06-12

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 43063734
Hyphenated Format 43063-734

Supplemental Identifiers

RxCUI
151226
UPC
0343063734308
UNII
0H73WJJ391
NUI
N0000008486 N0000185506 N0000182140

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 ANDA076343 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 7 TABLET in 1 BOTTLE, PLASTIC (43063-734-07)
  • 21 TABLET in 1 BOTTLE, PLASTIC (43063-734-21)
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-734-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (43063-734-60)
source: ndc

Packages (4)

43063-734-07 7 TABLET in 1 BOTTLE, PLASTIC (43063-734-07) 43063-734-21 21 TABLET in 1 BOTTLE, PLASTIC (43063-734-21) 43063-734-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-734-30) 43063-734-60 60 TABLET in 1 BOTTLE, PLASTIC (43063-734-60)

Ingredients (1)

topiramate (50 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": "39f9738a-570e-d6a6-e063-6294a90ac1ba", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0343063734308"], "unii": ["0H73WJJ391"], "rxcui": ["151226"], "spl_set_id": ["e39d2549-b489-426d-b576-741537e112e7"], "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": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "7 TABLET in 1 BOTTLE, PLASTIC (43063-734-07)", "package_ndc": "43063-734-07", "marketing_start_date": "20170307"}, {"sample": false, "description": "21 TABLET in 1 BOTTLE, PLASTIC (43063-734-21)", "package_ndc": "43063-734-21", "marketing_start_date": "20170131"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-734-30)", "package_ndc": "43063-734-30", "marketing_start_date": "20170104"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (43063-734-60)", "package_ndc": "43063-734-60", "marketing_start_date": "20161228"}], "brand_name": "Topiramate", "product_id": "43063-734_39f9738a-570e-d6a6-e063-6294a90ac1ba", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "43063-734", "generic_name": "Topiramate", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "50 mg/1"}], "application_number": "ANDA076343", "marketing_category": "ANDA", "marketing_start_date": "20140612", "listing_expiration_date": "20261231"}