Isotretinoin Capsule, Liquid Filled
NDC Package 68308-784-30

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

Package Information

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, liquid filled delivery system. Marketed by Mayne Pharma, this product is identified by NDC 68308-784 and is authorized under FDA application ANDA076485.

Identification & Billing

NDC Package Code
68308-784-30
Package Description
3 BLISTER PACK in 1 BOX / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-784-01)
Product Code
68308-784
11-Digit Billing Format
68308078430
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Isotretinoin
Non-Proprietary Name
Isotretinoin
Substance Name
Isotretinoin
Dosage Form
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ISOTRETINOIN 40 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
Mayne Pharma
Product Type
Human Prescription Drug
FDA Application #
ANDA076485
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-01-2012
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 68308-784-30 identifies a specific commercial package of 3 blister pack in 1 box / 10 capsule, liquid filled in 1 blister pack (68308-784-01) of Isotretinoin, a human prescription drug labeled by Mayne Pharma. This capsule, liquid filled 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 Mayne Pharma on May 01, 2012. 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 Mayne Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68308078430. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 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)
68308-784-30
11-Digit CMS (5-4-2)
68308-0784-30

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