felbamate

Generic: felbamate

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name felbamate
Generic Name felbamate
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

felbamate 600 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-735
Product ID 53746-735_b9ac064d-eed2-4d3c-b984-c9ebcef68646
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201680
Listing Expiration 2026-12-31
Marketing Start 2022-08-10

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 53746735
Hyphenated Format 53746-735

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 ANDA201680 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 180 TABLET in 1 BOTTLE (53746-735-18)
  • 30 TABLET in 1 BOTTLE (53746-735-30)
  • 90 TABLET in 1 BOTTLE (53746-735-90)
source: ndc

Packages (3)

53746-735-18 180 TABLET in 1 BOTTLE (53746-735-18) 53746-735-30 30 TABLET in 1 BOTTLE (53746-735-30) 53746-735-90 90 TABLET in 1 BOTTLE (53746-735-90)

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": "b9ac064d-eed2-4d3c-b984-c9ebcef68646", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["X72RBB02N8"], "rxcui": ["198358", "198359"], "spl_set_id": ["1aa40de5-c02d-49d6-8722-ed88c40c3ba6"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET in 1 BOTTLE (53746-735-18)", "package_ndc": "53746-735-18", "marketing_start_date": "20220810"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (53746-735-30)", "package_ndc": "53746-735-30", "marketing_start_date": "20220810"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (53746-735-90)", "package_ndc": "53746-735-90", "marketing_start_date": "20220810"}], "brand_name": "Felbamate", "product_id": "53746-735_b9ac064d-eed2-4d3c-b984-c9ebcef68646", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "53746-735", "generic_name": "Felbamate", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Felbamate", "active_ingredients": [{"name": "FELBAMATE", "strength": "600 mg/1"}], "application_number": "ANDA201680", "marketing_category": "ANDA", "marketing_start_date": "20220810", "listing_expiration_date": "20261231"}