NDC Package 16571-115-01 Hydroxyzine Hydrochloride

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

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:
Package Description:
Product Code:
Proprietary Name:
Hydroxyzine Hydrochloride
Non-Proprietary Name:
Hydroxyzine Hydrochloride
Substance Name:
Hydroxyzine Dihydrochloride
Usage Information:
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus.As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.
11-Digit NDC Billing Format:
NDC to RxNorm Crosswalk:
  • RxCUI: 995218 - hydrOXYzine HCl 10 MG Oral Tablet
  • RxCUI: 995218 - hydroxyzine hydrochloride 10 MG Oral Tablet
  • RxCUI: 995258 - hydrOXYzine HCl 25 MG Oral Tablet
  • RxCUI: 995258 - hydroxyzine hydrochloride 25 MG Oral Tablet
  • RxCUI: 995281 - hydrOXYzine HCl 50 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Rising Pharma Holdings, Inc.
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Sample Package:
    FDA Application Number:
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    Listing Expiration Date:
    Exclude Flag:
    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
    16571-115-101000 TABLET, FILM COATED in 1 BOTTLE
    16571-115-50500 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 16571-115-01?

    The NDC Packaged Code 16571-115-01 is assigned to a package of 100 tablet, film coated in 1 bottle of Hydroxyzine Hydrochloride, a human prescription drug labeled by Rising Pharma Holdings, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 16571-115 included in the NDC Directory?

    Yes, Hydroxyzine Hydrochloride with product code 16571-115 is active and included in the NDC Directory. The product was first marketed by Rising Pharma Holdings, Inc. on August 22, 2023 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 11-digit format for NDC 16571-115-01?

    The 11-digit format is 16571011501. 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