Imiquimod Cream
NDC Package 51672-4174-9

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

Package Information

Imiquimod cream is a medication used to treat certain types of growths on the skin. This formulation utilizes a cream delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 51672-4174 and is authorized under FDA application ANDA205971.

Identification & Billing

NDC Package Code
51672-4174-9
Package Description
1 BOTTLE, PUMP in 1 CARTON / 7.5 g in 1 BOTTLE, PUMP
Product Code
51672-4174
11-Digit Billing Format
51672417409
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
7.5 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Imiquimod
Non-Proprietary Name
Imiquimod
Substance Name
Imiquimod
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)
IMIQUIMOD 37.5 mg/g
Pharmacologic Class
Usage Information
This medication is used to treat certain types of growths on the skin. These are precancerous growths (actinic keratoses), a certain type of skin cancer (superficial basal cell carcinoma), and warts on the outside of the genitals/anus. Treating these conditions can decrease complications from them. Imiquimod belongs to a group of drugs called immune response modifiers. It is believed to work by helping to activate your immune system to fight these abnormal skin growths. This product is not recommended for use on children under 12 years of age unless specifically directed by your doctor.

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA205971
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-26-2021
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 (51672-4174). Click a package code to view its specific billing and regulatory data.

51672-4174-6
28 PACKET in 1 CARTON / .25 g in 1 PACKET (51672-4174-8)

* 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 51672-4174-9 identifies a specific commercial package of 1 bottle, pump in 1 carton / 7.5 g in 1 bottle, pump of Imiquimod, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This cream is formulated for topical use and contains imiquimod 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 Sun Pharmaceutical Industries, Inc. on January 26, 2021. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat certain types of growths on the skin. These are precancerous growths (actinic keratoses), a certain type of skin cancer (superficial basal cell carcinoma), and warts on the outside of the genitals/anus. Treating these conditions can decrease complications from them. Imiquimod belongs to a group of drugs called immune response modifiers. It is believed to work by helping to activate your immune system to fight these abnormal skin growths. This product is not recommended for use on children under 12 years of age unless specifically directed by your doctor.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51672417409. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 7.5 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 (5-4-1)
51672-4174-9
11-Digit CMS (5-4-2)
51672-4174-09

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