Topiramate

Generic: Topiramate

Labeler: REMEDYREPACK INC.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Active

Drug Facts

Product Profile

Brand Name Topiramate
Generic Name Topiramate
Labeler REMEDYREPACK INC.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

TOPIRAMATE 25 mg/1

Identifiers & Regulatory

Product NDC 70518-2899
Product ID 70518-2899_39e5fcf7-1342-db83-e063-6294a90aae93
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077627
Listing Expiration 2026-12-31
Marketing Start 2020-09-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705182899
Hyphenated Format 70518-2899

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 ANDA077627 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 POUCH in 1 BOX (70518-2899-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-2899-1)
source: ndc

Packages (1)

70518-2899-0 30 POUCH in 1 BOX (70518-2899-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-2899-1)

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": "39e5fcf7-1342-db83-e063-6294a90aae93", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "unii": ["0H73WJJ391"], "rxcui": ["199888"], "spl_set_id": ["edfec590-a303-4763-95a6-dfcc7602325d"], "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": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 BOX (70518-2899-0)  / 1 TABLET, FILM COATED in 1 POUCH (70518-2899-1)", "package_ndc": "70518-2899-0", "marketing_start_date": "20200930"}], "brand_name": "Topiramate", "product_id": "70518-2899_39e5fcf7-1342-db83-e063-6294a90aae93", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "70518-2899", "generic_name": "Topiramate", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "25 mg/1"}], "application_number": "ANDA077627", "marketing_category": "ANDA", "marketing_start_date": "20200930", "listing_expiration_date": "20261231"}