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  5. NDC Package Code: 63629-9604-1 Lidocaine And Prilocaine

NDC Package 63629-9604-1 Lidocaine And Prilocaine

Cream Topical - 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:
63629-9604-1
Package Description:
1 TUBE in 1 CARTON / 30 g in 1 TUBE
Product Code:
63629-9604
Proprietary Name:
Lidocaine And Prilocaine
Non-Proprietary Name:
Lidocaine And Prilocaine
Substance Name:
Lidocaine; Prilocaine
Usage Information:
Lidocaine and Prilocaine Cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on:• normal intact skin for local analgesia.• genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia.Lidocaine and Prilocaine Cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS).
11-Digit NDC Billing Format:
63629960401
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
30 GM
NDC to RxNorm Crosswalk:
  • RxCUI: 197877 - lidocaine 2.5 % / prilocaine 2.5 % Topical Cream
  • RxCUI: 197877 - lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical Cream
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bryant Ranch Prepack
    Dosage Form:
    Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
    Administration Route(s):
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Active Ingredient(s):
  • LIDOCAINE 25 mg/g
  • PRILOCAINE 25 mg/g
    • Pharmacologic Class(es):
  • Amide Local Anesthetic - [EPC] (Established Pharmacologic Class)
  • Amide Local Anesthetic - [EPC] (Established Pharmacologic Class)
  • Amides - [CS]
  • Antiarrhythmic - [EPC] (Established Pharmacologic Class)
  • Local Anesthesia - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    ANDA212482
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-05-2022
    Listing Expiration Date:
    12-31-2025
    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 63629-9604-1?

    The NDC Packaged Code 63629-9604-1 is assigned to a package of 1 tube in 1 carton / 30 g in 1 tube of Lidocaine And Prilocaine, a human prescription drug labeled by Bryant Ranch Prepack. The product's dosage form is cream and is administered via topical form.This product is billed per "GM" gram and contains an estimated amount of 30 billable units per package.

    Is NDC 63629-9604 included in the NDC Directory?

    Yes, Lidocaine And Prilocaine with product code 63629-9604 is active and included in the NDC Directory. The product was first marketed by Bryant Ranch Prepack on December 05, 2022 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 63629-9604-1?

    The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 63629-9604-1?

    The 11-digit format is 63629960401. 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 5-4-1 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
    5-4-163629-9604-15-4-263629-9604-01