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  5. NDC Package Code: 0641-6262-01 Sodium Acetate

NDC Package 0641-6262-01 Sodium Acetate

Injection Intravenous - 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:
0641-6262-01
Package Description:
1 VIAL in 1 CARTON / 50 mL in 1 VIAL
Product Code:
0641-6262
Proprietary Name:
Sodium Acetate
Non-Proprietary Name:
Sodium Acetate
Substance Name:
Sodium Acetate Anhydrous
Usage Information:
Sodium acetate injection (2 mEq/mL) is indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.
11-Digit NDC Billing Format:
00641626201
NDC to RxNorm Crosswalk:
  • RxCUI: 237371 - sodium acetate 2 MEQ/ML Injectable Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hikma Pharmaceuticals Usa Inc.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • SODIUM ACETATE ANHYDROUS 164 mg/mL
    • Pharmacologic Class(es):
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA216920
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-20-2024
    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 0641-6262-01?

    The NDC Packaged Code 0641-6262-01 is assigned to a package of 1 vial in 1 carton / 50 ml in 1 vial of Sodium Acetate, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 0641-6262 included in the NDC Directory?

    Yes, Sodium Acetate with product code 0641-6262 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmaceuticals Usa Inc. on May 20, 2024 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 0641-6262-01?

    The 11-digit format is 00641626201. 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
    4-4-20641-6262-015-4-200641-6262-01