Imiquimod
NDC Package 63629-8818-1

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Imiquimod is a medication used to treat certain types of growths on the skin. Marketed by Bryant Ranch Prepack, this product is identified by NDC 63629-8818 and is authorized under FDA application NDA022483.

Identification & Billing

NDC Package Code
63629-8818-1
Package Description
1 BOTTLE, PUMP in 1 CARTON / 7.5 g in 1 BOTTLE, PUMP
Product Code
63629-8818
11-Digit Billing Format
63629881801
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
7.5 GM

Clinical Specifications

Proprietary Name
Imiquimod
Dosage Form
-
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
Bryant Ranch Prepack
FDA Application #
NDA022483
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
07-30-2020
End Marketing Date
01-29-2026
Listing Expiration
01-29-2026
Exclude Flag
D
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 63629-8818-1 identifies a specific commercial package of 1 bottle, pump in 1 carton / 7.5 g in 1 bottle, pump of Imiquimod, labeled by Bryant Ranch Prepack. This product is billed per "GM" gram and contains an estimated amount of 7.5 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Bryant Ranch Prepack on July 30, 2020. The current certification is valid through January 29, 2026.

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 Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63629881801. 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)
63629-8818-1
11-Digit CMS (5-4-2)
63629-8818-01

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