Hydroquinone Cream
NDC Package 69367-174-01

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

Package Information

Hydroquinone cream is hydroquinone is used to lighten the dark patches of skin (also called hyperpigmentation, melasma, "liver spots," "age spots," freckles) caused by pregnancy, birth control pills, hormone medicine, or injury to the skin. This formulation utilizes a cream delivery system. Marketed by Westminster Pharmaceuticals, Llc, this product is identified by NDC 69367-174.

Identification & Billing

NDC Package Code
69367-174-01
Package Description
1 TUBE in 1 CARTON / 28.35 g in 1 TUBE
Product Code
69367-174
11-Digit Billing Format
69367017401
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
28.35 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hydroquinone
Non-Proprietary Name
Hydroquinone
Substance Name
Hydroquinone
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)
HYDROQUINONE 40 mg/g
Pharmacologic Class
Usage Information
Hydroquinone is used to lighten the dark patches of skin (also called hyperpigmentation, melasma, "liver spots," "age spots," freckles) caused by pregnancy, birth control pills, hormone medicine, or injury to the skin. This medicine works by blocking the process in the skin that leads to discoloration.

Regulatory & Marketing

Labeler Name
Westminster Pharmaceuticals, Llc
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
04-16-2018
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 69367-174-01 identifies a specific commercial package of 1 tube in 1 carton / 28.35 g in 1 tube of Hydroquinone, a human prescription drug labeled by Westminster Pharmaceuticals, Llc. This cream is formulated for topical use and contains hydroquinone 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 Westminster Pharmaceuticals, Llc on April 16, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Hydroquinone is used to lighten the dark patches of skin (also called hyperpigmentation, melasma, "liver spots," "age spots," freckles) caused by pregnancy, birth control pills, hormone medicine, or injury to the skin. This medicine works by blocking the process in the skin that leads to discoloration.

How is this Westminster Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69367017401. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 28.35 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)
69367-174-01
11-Digit CMS (5-4-2)
69367-0174-01

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