NDC directory

Topiramate

Cranbury Pharmaceuticals, LLC · CAPSULE, EXTENDED RELEASE

27808-327ANDACytochrome P450 2C19 Inhibitors [MoA]
Product NDC
27808-327
Generic name
Topiramate
Labeler name
Cranbury Pharmaceuticals, LLC
Brand name
Topiramate
Finished
true
Listing expiration date
20271231
Marketing category
ANDA
Dosage form
CAPSULE, EXTENDED RELEASE
SPL ID
82389c83-d085-4c1a-ab9c-480b4f9c6058
Product type
HUMAN PRESCRIPTION DRUG
Marketing start date
20261001
Product ID
27808-327_82389c83-d085-4c1a-ab9c-480b4f9c6058
Application number
ANDA218695
Brand name base
Topiramate
Active ingredients
  1. Name
    TOPIRAMATE
    Strength
    100 mg/1
Packaging
  1. Package NDC
    27808-327-01
    Description
    30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27808-327-01)
    Marketing start date
    20261001
    Sample
    false
Route
ORAL
Pharm class
Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.