NDC 0037-0430-01 Felbatol

Felbamate

NDC Package Code 0037-0430-01

The NDC Code 0037-0430-01 is assigned to a package of 100 tablet in 1 bottle, plastic of Felbatol, a human prescription drug labeled by Meda Pharmaceuticals. The product's dosage form is tablet and is administered via oral form.

Field Name Field Value
NDC Code 0037-0430-01
Package Description 100 TABLET in 1 BOTTLE, PLASTIC
Proprietary Name Felbatol What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Felbamate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Drug Uses Felbamate is used to treat severe seizures. This medication should be used only when you cannot take other medications or when other medications have not been able to control your seizures. Felbamate is known as an anticonvulsant or anti-epileptic drug.
11-Digit NDC Billing Format 00037043001 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Billing Unit EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Product Type Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Labeler Name Meda Pharmaceuticals
Dosage Form Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s)
  • Oral - Administration to or by way of the mouth.
Active Ingredient(s)
  • FELBAMATE 400 mg/1
Pharmacological Class(es)
  • Anti-epileptic Agent - [EPC] (Established Pharmacologic Class)
  • Decreased Central Nervous System Disorganized Electrical Activity - [PE] (Physiologic Effect)
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NDA020189 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Start Marketing Date 07-29-1993 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

NDC Code Structure

  • 0037 - Meda Pharmaceuticals
    • 0037-0430 - Felbatol
      • 0037-0430-01 - 100 TABLET in 1 BOTTLE, PLASTIC

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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National Average Drug Acquisition Cost (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average drug invoice price paid by retail community pharmacies to wholesalers. The Centers for Medicare and Medicaid Services (CMS) compile the NADAC data based on random monthly surveys on more than 60,000 pharmacies from all 50 states and the District of Columbia. NADAC pricing information is NOT the price paid by end-customers but instead the price paid by pharmacies to drug wholesalers and distributors.

Field Name Field Value
Price per Unit $12.72023
Effective Date 01-12-2021 Effective Date
The effective date of the NADAC Per Unit cost.
Pricing Unit EA Pricing Unit
Indicates the pricing unit for the associated NDC (ML, GM or EA).
Pharmacy Type Indicator C/I - Chain or Independent Pharmacy Pharmacy Type Indicator
The source of pharmacy survey data used to calculate the NADAC. 'C/I' indicates data was collected from surveys of Chain/Independent pharmacies. Other pharmacy type indicators are not used at this time.
Explanation Code Code 4: The NADAC was carried forward from the previous file. Explanation Code
The source of pharmacy survey data used to calculate the NADAC. 'C/I' indicates data was collected from surveys of Chain/Independent pharmacies. Other pharmacy type indicators are not used at this time.
Classification for Rate Setting B - Brand Classification for Rate Setting
Indicates whether the NDC was considered brand (B) or generic (G) for the NADAC rate calculation process. If the NDC was considered brand (B) and approved under an Abbreviated New Drug Application (ANDA), the indicator is shown as (B-ANDA).
Corresponding Generic Drug NADAC Per Unit 2.05645 Corresponding Generic Drug NADAC Per Unit
The NADAC for the corresponding generic drug.
Corresponding Generic Drug Effective Date 11/18/2020 Corresponding Generic Drug Effective Date
The effective date of when the Corresponding Generic Drug NADAC Per Unit is assigned to a multiple source brand drug NDC. This date may not correspond to the NADAC effective date for the generic drug due to the method by which the corresponding generic drug NADAC effective date is assigned.
As of Date 06-02-2021

* Please review the disclaimer below.