Acyclovir Ointment
NDC Package 85957-036-01

11-digit billing NDC: 85957003601
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Acyclovir ointment is 5% is indicated in the management of initial genital herpes and in limited non-life threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients. This formulation utilizes a ointment delivery system. Marketed by Aryeh Pharma Corp, this product is identified by NDC 85957-036 and is authorized under FDA application ANDA202459.

Identification & Billing

NDC Package Code
85957-036-01
Package Description
2 TUBE in 1 CARTON / 5 g in 1 TUBE
Product Code
85957-036
11-Digit Billing Format
85957003601
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Acyclovir
Non-Proprietary Name
Acyclovir
Substance Name
Acyclovir
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
ACYCLOVIR 50 mg/g
Pharmacologic Class
Usage Information
Acyclovir ointment 5% is indicated in the management of initial genital herpes and in limited non-life threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.

Regulatory & Marketing

Labeler Name
Aryeh Pharma Corp
Product Type
Human Prescription Drug
FDA Application #
ANDA202459
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-10-2026
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (85957-036). Click a package code to view its specific billing and regulatory data.

85957-036-02
1 TUBE in 1 CARTON / 15 g in 1 TUBE
85957-036-03
1 TUBE in 1 CARTON / 30 g in 1 TUBE

* 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 85957-036-01 identifies a specific commercial package of 2 tube in 1 carton / 5 g in 1 tube of Acyclovir, a human prescription drug labeled by Aryeh Pharma Corp. This ointment is formulated for topical use and contains acyclovir 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 Aryeh Pharma Corp on April 10, 2026. The current certification is valid through December 31, 2027.

How is this Aryeh Pharma Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85957003601. 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 (5-3-2)
85957-036-01
11-Digit CMS (5-4-2)
85957-0036-01

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