felbamate

Generic: felbamate

Labeler: viona pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

felbamate 600 mg/1

Manufacturer
Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-057
Product ID 72578-057_e719dd84-3938-4531-871c-4433fec8f4a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208970
Listing Expiration 2027-12-31
Marketing Start 2020-03-03

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 72578057
Hyphenated Format 72578-057

Supplemental Identifiers

RxCUI
198358 198359
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 ANDA208970 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (72578-057-01)
  • 500 TABLET in 1 BOTTLE (72578-057-05)
  • 30 TABLET in 1 BOTTLE (72578-057-06)
  • 90 TABLET in 1 BOTTLE (72578-057-16)
  • 180 TABLET in 1 BOTTLE (72578-057-28)
  • 10 BLISTER PACK in 1 CARTON (72578-057-77) / 10 TABLET in 1 BLISTER PACK (72578-057-30)
source: ndc

Packages (6)

72578-057-01 100 TABLET in 1 BOTTLE (72578-057-01) 72578-057-05 500 TABLET in 1 BOTTLE (72578-057-05) 72578-057-06 30 TABLET in 1 BOTTLE (72578-057-06) 72578-057-16 90 TABLET in 1 BOTTLE (72578-057-16) 72578-057-28 180 TABLET in 1 BOTTLE (72578-057-28) 72578-057-77 10 BLISTER PACK in 1 CARTON (72578-057-77) / 10 TABLET in 1 BLISTER PACK (72578-057-30)

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": "e719dd84-3938-4531-871c-4433fec8f4a6", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["X72RBB02N8"], "rxcui": ["198358", "198359"], "spl_set_id": ["96f4357c-720c-4651-b638-7b1181531dc5"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (72578-057-01)", "package_ndc": "72578-057-01", "marketing_start_date": "20200303"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (72578-057-05)", "package_ndc": "72578-057-05", "marketing_start_date": "20200303"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (72578-057-06)", "package_ndc": "72578-057-06", "marketing_start_date": "20200303"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (72578-057-16)", "package_ndc": "72578-057-16", "marketing_start_date": "20200303"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (72578-057-28)", "package_ndc": "72578-057-28", "marketing_start_date": "20200303"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (72578-057-77)  / 10 TABLET in 1 BLISTER PACK (72578-057-30)", "package_ndc": "72578-057-77", "marketing_start_date": "20200303"}], "brand_name": "Felbamate", "product_id": "72578-057_e719dd84-3938-4531-871c-4433fec8f4a6", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "72578-057", "generic_name": "Felbamate", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Felbamate", "active_ingredients": [{"name": "FELBAMATE", "strength": "600 mg/1"}], "application_number": "ANDA208970", "marketing_category": "ANDA", "marketing_start_date": "20200303", "listing_expiration_date": "20271231"}