felbamate

Generic: felbamate

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

felbamate 400 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-730
Product ID 62559-730_76100661-b064-4f19-b9ba-8ba4adcf042f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202284
Listing Expiration 2026-12-31
Marketing Start 2018-09-04

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 62559730
Hyphenated Format 62559-730

Supplemental Identifiers

RxCUI
198358 198359
UPC
0362559730013 0362559731010
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 ANDA202284 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (62559-730-01)
source: ndc

Packages (1)

62559-730-01 100 TABLET in 1 BOTTLE (62559-730-01)

Ingredients (1)

felbamate (400 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": "76100661-b064-4f19-b9ba-8ba4adcf042f", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0362559730013", "0362559731010"], "unii": ["X72RBB02N8"], "rxcui": ["198358", "198359"], "spl_set_id": ["17850520-f823-4d05-8f9b-5eadfa68bae2"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (62559-730-01)", "package_ndc": "62559-730-01", "marketing_start_date": "20180904"}], "brand_name": "Felbamate", "product_id": "62559-730_76100661-b064-4f19-b9ba-8ba4adcf042f", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "62559-730", "generic_name": "Felbamate", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Felbamate", "active_ingredients": [{"name": "FELBAMATE", "strength": "400 mg/1"}], "application_number": "ANDA202284", "marketing_category": "ANDA", "marketing_start_date": "20180904", "listing_expiration_date": "20261231"}