Acyclovir Injection, Powder, Lyophilized, For Solution
NDC Package 0143-9657-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Acyclovir injection is acyclovir is used to treat infections caused by certain types of viruses. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0143-9657 and is authorized under FDA application ANDA205771.

Identification & Billing

NDC Package Code
0143-9657-10
Package Description
10 VIAL, SINGLE-DOSE in 1 BOX / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9657-01)
Product Code
0143-9657
11-Digit Billing Format
00143965710
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Acyclovir
Non-Proprietary Name
Acyclovir
Substance Name
Acyclovir Sodium
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ACYCLOVIR SODIUM 500 mg/1
Pharmacologic Class
Usage Information
Acyclovir is used to treat infections caused by certain types of viruses. It treats cold sores around the mouth (caused by herpes simplex), shingles (caused by herpes zoster), and chickenpox. This medication is also used to treat outbreaks of genital herpes. In people with frequent outbreaks, acyclovir is used to help reduce the number of future episodes. Acyclovir is an antiviral drug. However, it is not a cure for these infections. The viruses that cause these infections continue to live in the body even between outbreaks. Acyclovir decreases the severity and length of these outbreaks. It helps the sores heal faster, keeps new sores from forming, and decreases pain/itching. This medication may also help reduce how long pain remains after the sores heal. In addition, in people with a weakened immune system, acyclovir can decrease the risk of the virus spreading to other parts of the body and causing serious infections.

Regulatory & Marketing

Labeler Name
Hikma Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA205771
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-29-2016
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0143-9657-10 identifies a specific commercial package of 10 vial, single-dose in 1 box / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose (0143-9657-01) of Acyclovir, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains acyclovir sodium as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Hikma Pharmaceuticals Usa Inc. on February 29, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Acyclovir is used to treat infections caused by certain types of viruses. It treats cold sores around the mouth (caused by herpes simplex), shingles (caused by herpes zoster), and chickenpox. This medication is also used to treat outbreaks of genital herpes. In people with frequent outbreaks, acyclovir is used to help reduce the number of future episodes. Acyclovir is an antiviral drug. However, it is not a cure for these infections. The viruses that cause these infections continue to live in the body even between outbreaks. Acyclovir decreases the severity and length of these outbreaks. It helps the sores heal faster, keeps new sores from forming, and decreases pain/itching. This medication may also help reduce how long pain remains after the sores heal. In addition, in people with a weakened immune system, acyclovir can decrease the risk of the virus spreading to other parts of the body and causing serious infections.

How is this Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00143965710. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0143-9657-10
11-Digit CMS (5-4-2)
00143-9657-10

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.