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  5. NDC Package Code: 69238-1258-3 Isotretinoin

NDC Package 69238-1258-3 Isotretinoin

Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
69238-1258-3
Package Description:
3 BLISTER PACK in 1 BOX / 10 CAPSULE in 1 BLISTER PACK (69238-1258-4)
Product Code:
69238-1258
Proprietary Name:
Isotretinoin
Non-Proprietary Name:
Isotretinoin
Substance Name:
Isotretinoin
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.
11-Digit NDC Billing Format:
69238125803
Product Type:
Human Prescription Drug
Labeler Name:
Amneal Pharmaceuticals Ny Llc
Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
ISOTRETINOIN 35 mg/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA216097
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
10-10-2025
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 69238-1258-3?

The NDC Packaged Code 69238-1258-3 is assigned to a package of 3 blister pack in 1 box / 10 capsule in 1 blister pack (69238-1258-4) of Isotretinoin, a human prescription drug labeled by Amneal Pharmaceuticals Ny Llc. The product's dosage form is capsule and is administered via oral form.

Is NDC 69238-1258 included in the NDC Directory?

Yes, Isotretinoin with product code 69238-1258 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Ny Llc on October 10, 2025.

What is the 11-digit format for NDC 69238-1258-3?

The 11-digit format is 69238125803. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-169238-1258-35-4-269238-1258-03