eprontia

Generic: topiramate

Labeler: azurity pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name eprontia
Generic Name topiramate
Labeler azurity pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

topiramate 25 mg/mL

Manufacturer
Azurity Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 52652-9001
Product ID 52652-9001_30dc8c36-63cc-07b4-e063-6294a90a9abb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214679
Listing Expiration 2026-12-31
Marketing Start 2021-12-06

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 526529001
Hyphenated Format 52652-9001

Supplemental Identifiers

RxCUI
2586427 2586433
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 eprontia (source: ndc)
Generic Name topiramate (source: ndc)
Application Number NDA214679 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (52652-9001-1)
  • 1 BOTTLE in 1 CARTON (52652-9001-2) / 240 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (52652-9001-3) / 120 mL in 1 BOTTLE
source: ndc

Packages (3)

52652-9001-1 473 mL in 1 BOTTLE (52652-9001-1) 52652-9001-2 1 BOTTLE in 1 CARTON (52652-9001-2) / 240 mL in 1 BOTTLE 52652-9001-3 1 BOTTLE in 1 CARTON (52652-9001-3) / 120 mL in 1 BOTTLE

Ingredients (1)

topiramate (25 mg/mL)

Linked Drug Pages (1)

Eprontia ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "30dc8c36-63cc-07b4-e063-6294a90a9abb", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "unii": ["0H73WJJ391"], "rxcui": ["2586427", "2586433"], "spl_set_id": ["e2a4df59-fead-4a01-9021-9eda02c48010"], "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": ["Azurity Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (52652-9001-1)", "package_ndc": "52652-9001-1", "marketing_start_date": "20211206"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (52652-9001-2)  / 240 mL in 1 BOTTLE", "package_ndc": "52652-9001-2", "marketing_start_date": "20230102"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (52652-9001-3)  / 120 mL in 1 BOTTLE", "package_ndc": "52652-9001-3", "marketing_start_date": "20230102"}], "brand_name": "Eprontia", "product_id": "52652-9001_30dc8c36-63cc-07b4-e063-6294a90a9abb", "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": "52652-9001", "generic_name": "Topiramate", "labeler_name": "Azurity Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eprontia", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "25 mg/mL"}], "application_number": "NDA214679", "marketing_category": "NDA", "marketing_start_date": "20211206", "listing_expiration_date": "20261231"}