felbamate

Generic: felbamate

Labeler: novitium pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name felbamate
Generic Name felbamate
Labeler novitium pharma llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

felbamate 600 mg/5mL

Manufacturer
Novitium Pharma LLC

Identifiers & Regulatory

Product NDC 70954-051
Product ID 70954-051_ca7073d4-4e4c-48b5-892a-2c33fa54062d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211333
Listing Expiration 2026-12-31
Marketing Start 2022-07-15

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 70954051
Hyphenated Format 70954-051

Supplemental Identifiers

RxCUI
310285
UPC
0370954051107 0370954051206
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 ANDA211333 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/5mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE (70954-051-10)
  • 473 mL in 1 BOTTLE (70954-051-20)
source: ndc

Packages (2)

70954-051-10 237 mL in 1 BOTTLE (70954-051-10) 70954-051-20 473 mL in 1 BOTTLE (70954-051-20)

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": "ca7073d4-4e4c-48b5-892a-2c33fa54062d", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0370954051107", "0370954051206"], "unii": ["X72RBB02N8"], "rxcui": ["310285"], "spl_set_id": ["81c8a2e1-732c-4467-84e9-53fef1655ee2"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Novitium Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE (70954-051-10)", "package_ndc": "70954-051-10", "marketing_start_date": "20220715"}, {"sample": false, "description": "473 mL in 1 BOTTLE (70954-051-20)", "package_ndc": "70954-051-20", "marketing_start_date": "20220715"}], "brand_name": "Felbamate", "product_id": "70954-051_ca7073d4-4e4c-48b5-892a-2c33fa54062d", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "70954-051", "generic_name": "Felbamate", "labeler_name": "Novitium Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Felbamate", "active_ingredients": [{"name": "FELBAMATE", "strength": "600 mg/5mL"}], "application_number": "ANDA211333", "marketing_category": "ANDA", "marketing_start_date": "20220715", "listing_expiration_date": "20261231"}