Acyclovir Cream
NDC Package 62332-423-05

11-digit billing NDC: 62332042305 · Billing unit: GM · 5 GM per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Acyclovir cream is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older. This formulation utilizes a cream delivery system. Marketed by Alembic Pharmaceuticals Inc., this product is identified by NDC 62332-423 and is authorized under FDA application ANDA212361.

Identification & Billing

NDC Package Code
62332-423-05
Package Description
1 TUBE in 1 CARTON / 5 g in 1 TUBE
Product Code
62332-423
11-Digit Billing Format
62332042305
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
5 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Acyclovir
Non-Proprietary Name
Acyclovir
Substance Name
Acyclovir
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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 cream is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older.

Regulatory & Marketing

Labeler Name
Alembic Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA212361
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-27-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 62332-423-05 identifies a specific commercial package of 1 tube in 1 carton / 5 g in 1 tube of Acyclovir, a human prescription drug labeled by Alembic Pharmaceuticals Inc.. This cream 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 Alembic Pharmaceuticals Inc. on November 27, 2023. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62332042305. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 5 total billable units per package. 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)
62332-423-05
11-Digit CMS (5-4-2)
62332-0423-05

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