Lidocaine Hydrochloride And Hydrocortisone Acetate Cream
NDC Package 69367-397-01

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

Lidocaine Hydrochloride And Hydrocortisone Acetate cream is product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area. This formulation utilizes a cream delivery system. Marketed by Westminster Pharmaceuticals, Llc, this product is identified by NDC 69367-397.

Identification & Billing

NDC Package Code
69367-397-01
Package Description
1 TUBE in 1 CARTON / 28.35 g in 1 TUBE
Product Code
69367-397
11-Digit Billing Format
69367039701
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
  • RxCUI: 1012235 - hydrocortisone acetate 0.5 % / lidocaine HCl 3 % Rectal Cream
  • RxCUI: 1012235 - hydrocortisone acetate 5 MG/ML / lidocaine hydrochloride 30 MG/ML Rectal Cream
  • RxCUI: 1012235 - hydrocortisone acetate 0.5 % / lidocaine hydrochloride 3 % Rectal Cream

Clinical Specifications

Proprietary Name
Lidocaine Hydrochloride And Hydrocortisone Acetate
Non-Proprietary Name
Lidocaine Hydrochloride And Hydrocortisone Acetate
Substance Name
Hydrocortisone Acetate; Lidocaine Hydrochloride
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)
Pharmacologic Class
Usage Information
Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.

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
11-15-2024
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 (69367-397). Click a package code to view its specific billing and regulatory data.

69367-397-85
1 TUBE in 1 CARTON / 85 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 69367-397-01 identifies a specific commercial package of 1 tube in 1 carton / 28.35 g in 1 tube of Lidocaine Hydrochloride And Hydrocortisone Acetate, a human prescription drug labeled by Westminster Pharmaceuticals, Llc. This cream is formulated for topical use and contains hydrocortisone acetate; lidocaine hydrochloride 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 November 15, 2024. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69367039701. 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)
69367-397-01
11-Digit CMS (5-4-2)
69367-0397-01

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