Renu Laboratories Acne Sulphur L Suspension
NDC Package 76348-450-02

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

Package Information

Renu Laboratories Acne Sulphur L (acne sulfur lotion) suspension is usesfor the treatment of acnehealing and drying acne breakoutshelps clear acne pimples, blackheads or whiteheads and allows skin to healpenetrates pores to control acne blemisheshelps keep skin clear of new acne pimples. This formulation utilizes a suspension delivery system. Marketed by Renu Laboratories, Llc, this product is identified by NDC 76348-450 and is authorized under FDA application M006.

Identification & Billing

NDC Package Code
76348-450-02
Package Description
56 g in 1 BOTTLE, GLASS
Product Code
76348-450
11-Digit Billing Format
76348045002
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Renu Laboratories Acne Sulphur L
Non-Proprietary Name
Acne Sulfur Lotion
Substance Name
Sulfur
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
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)
SULFUR 1.4 g/14g
Usage Information
Usesfor the treatment of acnehealing and drying acne breakoutshelps clear acne pimples, blackheads or whiteheads and allows skin to healpenetrates pores to control acne blemisheshelps keep skin clear of new acne pimples

Regulatory & Marketing

Labeler Name
Renu Laboratories, Llc
Product Type
Human Otc Drug
FDA Application #
M006
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-16-2015
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 76348-450-02 identifies a specific commercial package of 56 g in 1 bottle, glass of Renu Laboratories Acne Sulphur L, a human over the counter drug labeled by Renu Laboratories, Llc. This suspension is formulated for topical use and contains sulfur 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 Renu Laboratories, Llc on April 16, 2015. The current certification is valid through December 31, 2026.

How is this Renu Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76348045002. 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)
76348-450-02
11-Digit CMS (5-4-2)
76348-0450-02

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