felbamate

Generic: felbamate

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name felbamate
Generic Name felbamate
Labeler northstar rx llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

felbamate 600 mg/5mL

Manufacturer
NORTHSTAR RX LLC

Identifiers & Regulatory

Product NDC 16714-775
Product ID 16714-775_c3010d7b-f928-464e-af7c-ca45a5320a20
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206314
Listing Expiration 2026-12-31
Marketing Start 2018-04-10

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 16714775
Hyphenated Format 16714-775

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 ANDA206314 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/5mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE (16714-775-01)
  • 473 mL in 1 BOTTLE (16714-775-02)
source: ndc

Packages (2)

16714-775-01 237 mL in 1 BOTTLE (16714-775-01) 16714-775-02 473 mL in 1 BOTTLE (16714-775-02)

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": "c3010d7b-f928-464e-af7c-ca45a5320a20", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["X72RBB02N8"], "rxcui": ["310285"], "spl_set_id": ["556de35d-3b98-48d3-a670-50e9d93437a4"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["NORTHSTAR RX LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE (16714-775-01)", "package_ndc": "16714-775-01", "marketing_start_date": "20180410"}, {"sample": false, "description": "473 mL in 1 BOTTLE (16714-775-02)", "package_ndc": "16714-775-02", "marketing_start_date": "20180410"}], "brand_name": "Felbamate", "product_id": "16714-775_c3010d7b-f928-464e-af7c-ca45a5320a20", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "16714-775", "generic_name": "Felbamate", "labeler_name": "NORTHSTAR RX LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Felbamate", "active_ingredients": [{"name": "FELBAMATE", "strength": "600 mg/5mL"}], "application_number": "ANDA206314", "marketing_category": "ANDA", "marketing_start_date": "20180410", "listing_expiration_date": "20261231"}