NDC Package 68001-162-08 Promethazine Hydrochloride

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:
68001-162-08
Package Description:
1000 TABLET in 1 BOTTLE
Product Code:
Proprietary Name:
Promethazine Hydrochloride
Non-Proprietary Name:
Promethazine Hydrochloride
Substance Name:
Promethazine Hydrochloride
Usage Information:
Promethazine Hydrochloride, is useful orally 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 of anesthesia 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:
68001016208
NDC to RxNorm Crosswalk:
  • RxCUI: 992438 - promethazine HCl 12.5 MG Oral Tablet
  • RxCUI: 992438 - promethazine hydrochloride 12.5 MG Oral Tablet
  • RxCUI: 992447 - promethazine HCl 25 MG Oral Tablet
  • RxCUI: 992447 - promethazine hydrochloride 25 MG Oral Tablet
  • RxCUI: 992475 - promethazine HCl 50 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bluepoint Laboratories
    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:
    ANDA040596
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-13-2014
    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
    68001-162-00100 TABLET in 1 BOTTLE
    68001-162-03500 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68001-162-08?

    The NDC Packaged Code 68001-162-08 is assigned to a package of 1000 tablet in 1 bottle of Promethazine Hydrochloride, a human prescription drug labeled by Bluepoint Laboratories. The product's dosage form is tablet and is administered via oral form.

    Is NDC 68001-162 included in the NDC Directory?

    Yes, Promethazine Hydrochloride with product code 68001-162 is active and included in the NDC Directory. The product was first marketed by Bluepoint Laboratories on January 13, 2014 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 68001-162-08?

    The 11-digit format is 68001016208. 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
    5-3-268001-162-085-4-268001-0162-08