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  5. NDC Package Code: 63868-608-01 Oxymetazoline Hydrochloride

NDC Package 63868-608-01 Oxymetazoline Hydrochloride

Solution Nasal - 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:
63868-608-01
Package Description:
30 mL in 1 BOTTLE
Product Code:
63868-608
Proprietary Name:
Oxymetazoline Hydrochloride
Non-Proprietary Name:
Oxymetazoline Hydrochloride
Substance Name:
Oxymetazoline Hydrochloride
Usage Information:
Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10-12 hours. Do not exceed 2 doses in any 24-hour period. children under 6 years of age: ask a doctorShake well before use. To open, rotate cap to align the marks. Squeeze cap on both sides and turn in a counter-clockwise direction and pull off to remove. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting the head insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap back onto the bottle.
11-Digit NDC Billing Format:
63868060801
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
30 ML
Product Type:
Human Otc Drug
Labeler Name:
Chain Drug Marketing Association Inc
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s):
  • Nasal - Administration to the nose; administered by way of the nose.
    • Active Ingredient(s):
  • OXYMETAZOLINE HYDROCHLORIDE .05 mg/mL
    • Pharmacologic Class(es):
  • Imidazolines - [CS]
  • Increased Sympathetic Activity - [PE] (Physiologic Effect)
  • Vasoconstriction - [PE] (Physiologic Effect)
  • Vasoconstrictor - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    part341
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    03-15-2021
    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.

    Frequently Asked Questions

    What is NDC 63868-608-01?

    The NDC Packaged Code 63868-608-01 is assigned to a package of 30 ml in 1 bottle of Oxymetazoline Hydrochloride, a human over the counter drug labeled by Chain Drug Marketing Association Inc. The product's dosage form is solution and is administered via nasal form.This product is billed per "ML" milliliter and contains an estimated amount of 30 billable units per package.

    Is NDC 63868-608 included in the NDC Directory?

    Yes, Oxymetazoline Hydrochloride with product code 63868-608 is active and included in the NDC Directory. The product was first marketed by Chain Drug Marketing Association Inc on March 15, 2021 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 63868-608-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 63868-608-01?

    The 11-digit format is 63868060801. 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 5-3-2 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
    5-3-263868-608-015-4-263868-0608-01