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  5. NDC Package Code: 0555-1055-56 Claravis

NDC Package 0555-1055-56 Claravis

Isotretinoin Capsule, Liquid Filled Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
0555-1055-56
Package Description:
10 BLISTER PACK in 1 CARTON / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1055-60)
Product Code:
0555-1055
Proprietary Name:
Claravis
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:
00555105556
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
10 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 197843 - ISOtretinoin 10 MG Oral Capsule
  • RxCUI: 197843 - isotretinoin 10 MG Oral Capsule
  • RxCUI: 197844 - ISOtretinoin 20 MG Oral Capsule
  • RxCUI: 197844 - isotretinoin 20 MG Oral Capsule
  • RxCUI: 197845 - ISOtretinoin 40 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Teva Pharmaceuticals Usa, Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ISOTRETINOIN 20 mg/1
    • Pharmacologic Class(es):
  • Retinoid - [EPC] (Established Pharmacologic Class)
  • Retinoids - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA076135
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-09-2003
    Listing Expiration Date:
    12-31-2024
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0555-1055-863 BLISTER PACK in 1 CARTON / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1055-60)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0555-1055-56?

    The NDC Packaged Code 0555-1055-56 is assigned to a package of 10 blister pack in 1 carton / 10 capsule, liquid filled in 1 blister pack (0555-1055-60) of Claravis, a human prescription drug labeled by Teva Pharmaceuticals Usa, Inc.. The product's dosage form is capsule, liquid filled and is administered via oral form.

    Is NDC 0555-1055 included in the NDC Directory?

    Yes, Claravis with product code 0555-1055 is active and included in the NDC Directory. The product was first marketed by Teva Pharmaceuticals Usa, Inc. on May 09, 2003 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0555-1055-56?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 10.

    What is the 11-digit format for NDC 0555-1055-56?

    The 11-digit format is 00555105556. 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 4-4-2 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
    4-4-20555-1055-565-4-200555-1055-56