topiramate

Generic: topiramate

Labeler: ajanta pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

topiramate 200 mg/1

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-230
Product ID 27241-230_b29a0bc6-2706-4a91-a4cb-d8f9a2dd94a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215663
Listing Expiration 2027-12-31
Marketing Start 2023-08-15

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 27241230
Hyphenated Format 27241-230

Supplemental Identifiers

RxCUI
1436239 1437278 1437283 1437288
UPC
0327241228308 0327241227301 0327241230301 0327241229305
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 ANDA215663 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-230-01)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-230-30)
source: ndc

Packages (2)

27241-230-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-230-01) 27241-230-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-230-30)

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": "b29a0bc6-2706-4a91-a4cb-d8f9a2dd94a0", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0327241228308", "0327241227301", "0327241230301", "0327241229305"], "unii": ["0H73WJJ391"], "rxcui": ["1436239", "1437278", "1437283", "1437288"], "spl_set_id": ["b94629e3-ae2e-473e-b2f5-06e32ee19aa9"], "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": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-230-01)", "package_ndc": "27241-230-01", "marketing_start_date": "20230815"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-230-30)", "package_ndc": "27241-230-30", "marketing_start_date": "20230815"}], "brand_name": "Topiramate", "product_id": "27241-230_b29a0bc6-2706-4a91-a4cb-d8f9a2dd94a0", "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": "27241-230", "generic_name": "Topiramate", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "200 mg/1"}], "application_number": "ANDA215663", "marketing_category": "ANDA", "marketing_start_date": "20230815", "listing_expiration_date": "20271231"}