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  5. NDC Package Code: 67386-313-21 Onfi

NDC Package 67386-313-21 Onfi

Clobazam Suspension Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
67386-313-21
Package Description:
1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE
Product Code:
67386-313
Proprietary Name:
Onfi
Non-Proprietary Name:
Clobazam
Substance Name:
Clobazam
Usage Information:
This medication is used with other medications to help control seizures. It belongs to a class of medications called benzodiazepines, which act on the brain and nerves (central nervous system) to produce a calming effect. This drug works by enhancing the effects of a certain natural chemical in the body (GABA).
11-Digit NDC Billing Format:
67386031321
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1191056 - Onfi 10 MG Oral Tablet
  • RxCUI: 1191056 - clobazam 10 MG Oral Tablet [Onfi]
  • RxCUI: 1191058 - Onfi 20 MG Oral Tablet
  • RxCUI: 1191058 - clobazam 20 MG Oral Tablet [Onfi]
  • RxCUI: 1366192 - cloBAZam 2.5 MG in 1 mL Oral Suspension
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Lundbeck Pharmaceuticals Llc
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CLOBAZAM 2.5 mg/mL
    • Pharmacologic Class(es):
  • Benzodiazepine - [EPC] (Established Pharmacologic Class)
  • Benzodiazepines - [CS]
  • Cytochrome P450 2D6 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A4 Inducers - [MoA] (Mechanism of Action)
    • DEA Schedule:
    Schedule IV (CIV) Substances
    Sample Package:
    No
    FDA Application Number:
    NDA203993
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-14-2012
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 67386-313-21?

    The NDC Packaged Code 67386-313-21 is assigned to a package of 1 bottle in 1 carton / 120 ml in 1 bottle of Onfi, a human prescription drug labeled by Lundbeck Pharmaceuticals Llc. The product's dosage form is suspension and is administered via oral form.

    Is NDC 67386-313 included in the NDC Directory?

    Yes, Onfi with product code 67386-313 is active and included in the NDC Directory. The product was first marketed by Lundbeck Pharmaceuticals Llc on December 14, 2012 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 67386-313-21?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 67386-313-21?

    The 11-digit format is 67386031321. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-267386-313-215-4-267386-0313-21