NDC Package 54348-117-00 Promethazine

Tablet 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:
54348-117-00
Package Description:
1 BOTTLE in 1 BOX / 1 TABLET in 1 BOTTLE
Product Code:
Proprietary Name:
Promethazine
Non-Proprietary Name:
Promethazine
Substance Name:
Promethazine Hydrochloride
Usage Information:
Promethazine hydrochloride tablets, USP are useful for:Perennial and seasonal allergic rhinitis.Vasomotor rhinitis.Allergic conjunctivitis due to inhalant allergens and foods.Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.Amelioration of allergic reactions to blood or plasma.Dermographism.Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled.Preoperative, postoperative, or obstetric sedation.Prevention and control of nausea and vomiting associated with certain types ofanesthesia and surgery.Therapy adjunctive to meperidine or other analgesics for control of post-operative pain.Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.Active and prophylactic treatment of motion sickness.Antiemetic therapy in postoperative patients.
11-Digit NDC Billing Format:
54348011700
NDC to RxNorm Crosswalk:
  • RxCUI: 992447 - promethazine HCl 25 MG Oral Tablet
  • RxCUI: 992447 - promethazine hydrochloride 25 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Pharmpak, Inc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Sample Package:
    No
    FDA Application Number:
    ANDA040712
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-11-2019
    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
    54348-117-021 BOTTLE in 1 BOX / 2 TABLET in 1 BOTTLE
    54348-117-031 BOTTLE in 1 BOX / 3 TABLET in 1 BOTTLE
    54348-117-041 BOTTLE in 1 BOX / 4 TABLET in 1 BOTTLE
    54348-117-051 BOTTLE in 1 BOX / 5 TABLET in 1 BOTTLE
    54348-117-061 BOTTLE in 1 BOX / 6 TABLET in 1 BOTTLE
    54348-117-081 BOTTLE in 1 BOX / 8 TABLET in 1 BOTTLE
    54348-117-091 BOTTLE in 1 BOX / 9 TABLET in 1 BOTTLE
    54348-117-101 BOTTLE in 1 BOX / 10 TABLET in 1 BOTTLE
    54348-117-121 BOTTLE in 1 BOX / 12 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 54348-117-00?

    The NDC Packaged Code 54348-117-00 is assigned to a package of 1 bottle in 1 box / 1 tablet in 1 bottle of Promethazine, a human prescription drug labeled by Pharmpak, Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 54348-117 included in the NDC Directory?

    Yes, Promethazine with product code 54348-117 is active and included in the NDC Directory. The product was first marketed by Pharmpak, Inc. on July 11, 2019 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 54348-117-00?

    The 11-digit format is 54348011700. 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
    5-3-254348-117-005-4-254348-0117-00