felbamate

Generic: felbamate

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name felbamate
Generic Name felbamate
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

felbamate 600 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 51525-0431
Product ID 51525-0431_e30cfc72-328a-4cb8-b849-9e59a9dd9f34
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020189
Marketing Start 2011-11-11
Marketing End 2026-04-28

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]
Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 515250431
Hyphenated Format 51525-0431

Supplemental Identifiers

RxCUI
198358 198359 310285
UNII
X72RBB02N8
NUI
N0000175753 N0000008486

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 felbamate (source: ndc)
Generic Name felbamate (source: ndc)
Application Number NDA020189 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (51525-0431-1)
source: ndc

Packages (1)

51525-0431-1 100 TABLET in 1 BOTTLE (51525-0431-1)

Ingredients (1)

felbamate (600 mg/1)

Linked Drug Pages (1)

Felbamate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e30cfc72-328a-4cb8-b849-9e59a9dd9f34", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["X72RBB02N8"], "rxcui": ["198358", "198359", "310285"], "spl_set_id": ["c0c15d60-1171-11e1-9be0-0002a5d5c51b"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (51525-0431-1)", "package_ndc": "51525-0431-1", "marketing_end_date": "20260428", "marketing_start_date": "20111111"}], "brand_name": "Felbamate", "product_id": "51525-0431_e30cfc72-328a-4cb8-b849-9e59a9dd9f34", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "51525-0431", "generic_name": "felbamate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Felbamate", "active_ingredients": [{"name": "FELBAMATE", "strength": "600 mg/1"}], "application_number": "NDA020189", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_end_date": "20260428", "marketing_start_date": "20111111"}