felbamate

Generic: felbamate

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

Drug Facts

Product Profile

Brand Name felbamate
Generic Name felbamate
Labeler amneal pharmaceuticals llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

felbamate 600 mg/5mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-686
Product ID 65162-686_5ae2c0c1-5f34-4c23-bb17-169302c2253f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202385
Listing Expiration 2026-12-31
Marketing Start 2011-12-16

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 65162686
Hyphenated Format 65162-686

Supplemental Identifiers

RxCUI
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 ANDA202385 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/5mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE (65162-686-88)
  • 473 mL in 1 BOTTLE (65162-686-90)
source: ndc

Packages (2)

65162-686-88 237 mL in 1 BOTTLE (65162-686-88) 65162-686-90 473 mL in 1 BOTTLE (65162-686-90)

Ingredients (1)

felbamate (600 mg/5mL)

Linked Drug Pages (1)

Felbamate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5ae2c0c1-5f34-4c23-bb17-169302c2253f", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["X72RBB02N8"], "rxcui": ["310285"], "spl_set_id": ["2e325d79-d0a4-4af7-b09b-96ee5a5b2a37"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE (65162-686-88)", "package_ndc": "65162-686-88", "marketing_start_date": "20111216"}, {"sample": false, "description": "473 mL in 1 BOTTLE (65162-686-90)", "package_ndc": "65162-686-90", "marketing_start_date": "20111216"}], "brand_name": "Felbamate", "product_id": "65162-686_5ae2c0c1-5f34-4c23-bb17-169302c2253f", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "65162-686", "generic_name": "Felbamate", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Felbamate", "active_ingredients": [{"name": "FELBAMATE", "strength": "600 mg/5mL"}], "application_number": "ANDA202385", "marketing_category": "ANDA", "marketing_start_date": "20111216", "listing_expiration_date": "20261231"}