NDC Package 43547-454-10 Levetiracetam

Injection Intravenous - View Billable Units, 11-Digit Format, RxNorm

Package Information
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:

43547-454-10

Package Description:

10 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE (43547-454-41)

Product Code:

43547-454

Proprietary Name:

Levetiracetam

Non-Proprietary Name:

Levetiracetam

Substance Name:

Levetiracetam

Usage Information:

Levetiracetam is used to treat seizures (epilepsy). It belongs to a class of drugs known as anticonvulsants. Levetiracetam may decrease the number of seizures you have.

11-Digit NDC Billing Format:

43547045410

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

RxCUI: 647121 - levETIRAcetam 500 MG in 5 ML Injection

RxCUI: 647121 - 5 ML levetiracetam 100 MG/ML Injection

RxCUI: 647121 - levetiracetam 500 MG per 5 ML Injection

Product Type:

Human Prescription Drug

Labeler Name:

Solco Healthcare Us, Llc

Dosage Form:

Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.

Administration Route(s):

Intravenous - Administration within or into a vein or veins.

Active Ingredient(s):

LEVETIRACETAM 500 mg/5mL

Pharmacologic Class(es):

Decreased Central Nervous System Disorganized Electrical Activity - [PE] (Physiologic Effect)

Sample Package:

FDA Application Number:

ANDA209474

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

04-11-2022

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

43547 - Solco Healthcare Us, Llc
- 43547-454 - Levetiracetam
  - 43547-454-10 - 10 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE (43547-454-41)

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 43547-454-10?

The NDC Packaged Code 43547-454-10 is assigned to a package of 10 vial, single-dose in 1 carton / 5 ml in 1 vial, single-dose (43547-454-41) of Levetiracetam, a human prescription drug labeled by Solco Healthcare Us, Llc. The product's dosage form is injection and is administered via intravenous form.

Is NDC 43547-454 included in the NDC Directory?

Yes, Levetiracetam with product code 43547-454 is active and included in the NDC Directory. The product was first marketed by Solco Healthcare Us, Llc on April 11, 2022 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 43547-454-10?

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 43547-454-10?

The 11-digit format is 43547045410. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	43547-454-10	5-4-2	43547-0454-10

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