NDC Package 0404-9811-10 Amidate

Etomidate Injection, Solution Intravenous - 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:
0404-9811-10
Package Description:
1 VIAL, SINGLE-DOSE in 1 BAG / 10 mL in 1 VIAL, SINGLE-DOSE
Product Code:
Proprietary Name:
Amidate
Non-Proprietary Name:
Etomidate
Substance Name:
Etomidate
Usage Information:
AMIDATE is indicated by intravenous injection for the induction of general anesthesia. When considering use of AMIDATE, the usefulness of its hemodynamic properties (see CLINICAL PHARMACOLOGY) should be weighed against the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS).Intravenous AMIDATE is also indicated for the supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization.
11-Digit NDC Billing Format:
00404981110
Product Type:
Human Prescription Drug
Labeler Name:
Henry Schein, Inc.
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    NDA018227
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    01-06-2022
    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.

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    Frequently Asked Questions

    What is NDC 0404-9811-10?

    The NDC Packaged Code 0404-9811-10 is assigned to a package of 1 vial, single-dose in 1 bag / 10 ml in 1 vial, single-dose of Amidate, a human prescription drug labeled by Henry Schein, Inc.. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 0404-9811 included in the NDC Directory?

    Yes, Amidate with product code 0404-9811 is active and included in the NDC Directory. The product was first marketed by Henry Schein, Inc. on January 06, 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 11-digit format for NDC 0404-9811-10?

    The 11-digit format is 00404981110. 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 4-4-2 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
    4-4-20404-9811-105-4-200404-9811-10