felbatol

Generic: felbamate

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name felbatol
Generic Name felbamate
Labeler viatris specialty llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

felbamate 600 mg/1

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 0037-0431
Product ID 0037-0431_374f8c69-4219-47fd-aeda-8edc73da5411
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020189
Listing Expiration 2026-12-31
Marketing Start 1993-07-29

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 00370431
Hyphenated Format 0037-0431

Supplemental Identifiers

RxCUI
198358 198359 209026 209027 209028 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 felbatol (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, PLASTIC (0037-0431-01)
source: ndc

Packages (1)

0037-0431-01 100 TABLET in 1 BOTTLE, PLASTIC (0037-0431-01)

Ingredients (1)

felbamate (600 mg/1)

Linked Drug Pages (1)

Felbatol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "374f8c69-4219-47fd-aeda-8edc73da5411", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["X72RBB02N8"], "rxcui": ["198358", "198359", "209026", "209027", "209028", "310285"], "spl_set_id": ["2f522701-397a-11de-8a39-0800200c9a66"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0037-0431-01)", "package_ndc": "0037-0431-01", "marketing_start_date": "19930729"}], "brand_name": "Felbatol", "product_id": "0037-0431_374f8c69-4219-47fd-aeda-8edc73da5411", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "0037-0431", "generic_name": "felbamate", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Felbatol", "active_ingredients": [{"name": "FELBAMATE", "strength": "600 mg/1"}], "application_number": "NDA020189", "marketing_category": "NDA", "marketing_start_date": "19930729", "listing_expiration_date": "20261231"}