topiramate

Generic: topiramate

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

Drug Facts

Product Profile

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

topiramate 150 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-370
Product ID 68462-370_d205c367-b32b-487d-9ede-00da4fba8397
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210278
Listing Expiration 2027-12-31
Marketing Start 2021-02-01

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 68462370
Hyphenated Format 68462-370

Supplemental Identifiers

RxCUI
1494769 1812419 1812421 1812425 1812427
UPC
0368462374306 0368462371305 0368462372302 0368462373309
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 ANDA210278 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-370-05)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-370-30)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-370-90)
source: ndc

Packages (3)

68462-370-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-370-05) 68462-370-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-370-30) 68462-370-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-370-90)

Ingredients (1)

topiramate (150 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": "d205c367-b32b-487d-9ede-00da4fba8397", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0368462374306", "0368462371305", "0368462372302", "0368462373309"], "unii": ["0H73WJJ391"], "rxcui": ["1494769", "1812419", "1812421", "1812425", "1812427"], "spl_set_id": ["54bfabce-1f8a-40ee-8b55-efce8fe6fbf1"], "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": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-370-05)", "package_ndc": "68462-370-05", "marketing_start_date": "20210201"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-370-30)", "package_ndc": "68462-370-30", "marketing_start_date": "20210201"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-370-90)", "package_ndc": "68462-370-90", "marketing_start_date": "20210201"}], "brand_name": "TOPIRAMATE", "product_id": "68462-370_d205c367-b32b-487d-9ede-00da4fba8397", "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": "68462-370", "generic_name": "topiramate", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TOPIRAMATE", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "150 mg/1"}], "application_number": "ANDA210278", "marketing_category": "ANDA", "marketing_start_date": "20210201", "listing_expiration_date": "20271231"}