NDC Package 0641-6231-25 Hydralazine Hydrochloride

Injection, Solution Intramuscular; 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:
0641-6231-25
Package Description:
25 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE (0641-6231-01)
Product Code:
Proprietary Name:
Hydralazine Hydrochloride
Non-Proprietary Name:
Hydralazine Hydrochloride
Substance Name:
Hydralazine Hydrochloride
Usage Information:
Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.
11-Digit NDC Billing Format:
00641623125
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 966571 - hydrALAZINE HCl 20 MG in 1 ML Injection
  • RxCUI: 966571 - 1 ML hydralazine hydrochloride 20 MG/ML Injection
  • RxCUI: 966571 - hydralazine HCl 20 MG per 1 ML Injection
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hikma Pharmaceuticals Usa 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):
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Sample Package:
    No
    FDA Application Number:
    ANDA213667
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-18-2020
    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 0641-6231-25?

    The NDC Packaged Code 0641-6231-25 is assigned to a package of 25 vial, single-dose in 1 carton / 20 ml in 1 vial, single-dose (0641-6231-01) of Hydralazine Hydrochloride, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is injection, solution and is administered via intramuscular; intravenous form.

    Is NDC 0641-6231 included in the NDC Directory?

    Yes, Hydralazine Hydrochloride with product code 0641-6231 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmaceuticals Usa Inc. on December 18, 2020 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 0641-6231-25?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0641-6231-25?

    The 11-digit format is 00641623125. 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
    4-4-20641-6231-255-4-200641-6231-25