Zenatane Capsule, Gelatin Coated
NDC Package 55111-113-78

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

Zenatane (isotretinoin) capsules is a medication used to treat severe cystic acne (also known as nodular acne) that has not responded to other treatment (e.g., benzoyl peroxide or clindamycin applied to the skin or tetracycline or minocycline taken by mouth). This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Dr. Reddy's Laboratories Limited, this product is identified by NDC 55111-113 and is authorized under FDA application ANDA202099.

Identification & Billing

NDC Package Code
55111-113-78
Package Description
10 BLISTER PACK in 1 CARTON / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79)
Product Code
55111-113
11-Digit Billing Format
55111011378
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zenatane
Non-Proprietary Name
Isotretinoin
Substance Name
Isotretinoin
Dosage Form
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ISOTRETINOIN 30 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat severe cystic acne (also known as nodular acne) that has not responded to other treatment (e.g., benzoyl peroxide or clindamycin applied to the skin or tetracycline or minocycline taken by mouth). It belongs to a class of drugs known as retinoids. It works by decreasing facial oil (sebum) production. High amounts of sebum can lead to severe acne. If left untreated, severe acne may cause permanent scarring.

Regulatory & Marketing

Labeler Name
Dr. Reddy's Laboratories Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA202099
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-09-2015
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (55111-113). Click a package code to view its specific billing and regulatory data.

55111-113-81
3 BLISTER PACK in 1 CARTON / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79)

* 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 55111-113-78 identifies a specific commercial package of 10 blister pack in 1 carton / 10 capsule, gelatin coated in 1 blister pack (55111-113-79) of Zenatane, a human prescription drug labeled by Dr. Reddy's Laboratories Limited. This capsule, gelatin coated is formulated for oral use and contains isotretinoin 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 Dr. Reddy's Laboratories Limited on March 09, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat severe cystic acne (also known as nodular acne) that has not responded to other treatment (e.g., benzoyl peroxide or clindamycin applied to the skin or tetracycline or minocycline taken by mouth). It belongs to a class of drugs known as retinoids. It works by decreasing facial oil (sebum) production. High amounts of sebum can lead to severe acne. If left untreated, severe acne may cause permanent scarring.

How is this Dr. Reddy's Laboratories Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55111011378. 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)
55111-113-78
11-Digit CMS (5-4-2)
55111-0113-78

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