topiramate

Generic: topiramate

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler lupin pharmaceuticals, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

topiramate 200 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70748-278
Product ID 70748-278_8eaf61e7-2317-45ff-9cb0-18d2dbddc140
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215561
Listing Expiration 2027-12-31
Marketing Start 2026-02-03

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 70748278
Hyphenated Format 70748-278

Supplemental Identifiers

RxCUI
1436239 1437278 1437283 1437288
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 ANDA215561 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70748-278-06)
source: ndc

Packages (1)

70748-278-06 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70748-278-06)

Ingredients (1)

topiramate (200 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": "8eaf61e7-2317-45ff-9cb0-18d2dbddc140", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "unii": ["0H73WJJ391"], "rxcui": ["1436239", "1437278", "1437283", "1437288"], "spl_set_id": ["e310afcd-1260-434e-a994-34549c789d99"], "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": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70748-278-06)", "package_ndc": "70748-278-06", "marketing_start_date": "20260203"}], "brand_name": "Topiramate", "product_id": "70748-278_8eaf61e7-2317-45ff-9cb0-18d2dbddc140", "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": "70748-278", "generic_name": "Topiramate", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "200 mg/1"}], "application_number": "ANDA215561", "marketing_category": "ANDA", "marketing_start_date": "20260203", "listing_expiration_date": "20271231"}